Methods and apparatus for detecting motion via optomechanics

ABSTRACT

Methods and apparatus are described for facilitating the extraction of cleaner biometric signals from biometric monitors. A motion reference signal is generated independently from a biometric signal and then the motion reference signal is used to remove motion artifacts from the biometric signal.

RELATED APPLICATIONS

This application is a 35 U.S.C. § 371 national stage application of PCTApplication No. PCT/US2016/046273, filed Aug. 10, 2016, which itselfclaims the benefit of and priority to U.S. Provisional PatentApplication No. 62/204,214 filed Aug. 12, 2015, U.S. Provisional PatentApplication No. 62/257,502 filed Nov. 19, 2015, and U.S. ProvisionalPatent Application No. 62/345,579 filed Jun. 3, 2016, the disclosures ofall of which are incorporated herein by reference as if set forth intheir entireties. The above-referenced PCT International Application waspublished in the English language as International Publication No. WO2017/027551 A1 on Feb. 16, 2017.

FIELD OF THE INVENTION

io The present invention relates generally to monitoring devices andmethods and, more particularly, to monitoring devices and methods formeasuring physiological information.

BACKGROUND OF THE INVENTION

Wearable devices capable of monitoring physiological information, suchas heart rate, are increasingly being used. These devices come invarious form factors, including devices configured to be worn at the earor at other locations of the body, and including devices carried or wornby a person, such as smartphones, etc. U.S. Pat. Nos. 8,652,040,8,700,111, 8,647,270, 8,788,002, 8,886,269, and 8,929,965, which areincorporated herein by reference in their entireties, describe variouswearable devices configured to monitor physiological information,including headsets, earbuds, and wrist bands.

Physiological information obtained from a subject can be used togenerate various types of health and fitness assessments of the subject.For example, using a photoplethysmography (PPG) sensor incorporated intoa wearable monitoring device, blood flow information can be measuredduring daily activities of a subject and this information can be used togenerate assessments, such as maximum oxygen consumption VO₂max, totalenergy expenditure (TEE), etc.

Unfortunately, a biometric signal from a physiological sensor of awearable device typically includes subject motion-related noise, and PPGsensors are particularly sensitive to motion-related noise. Moreover,efforts to use accelerometer- or gyroscopic-based signals as motionnoise references for cleaning up PPG signals have seen limited success,as these motion-related signals do not perfectly represent the motionnoise characteristics reflected in PPG signals. As such, complex signalprocessing may be required in order to extract pure biometricinformation (i.e. heart rate, breathing rate) from motion-related noiseembedded in the sensor signal.

SUMMARY

It should be appreciated that this Summary is provided to introduce aselection of concepts in a simplified form, the concepts being furtherdescribed below in the Detailed Description. This Summary is notintended to identify key features or essential features of thisdisclosure, nor is it intended to limit the scope of the invention.

Embodiments of the present invention facilitate the extraction ofcleaner biometric signals from biometric monitors, such as PPG sensorsand the like, by generating a motion reference signal independently froma biometric signal and then using this motion reference signal to removemotion artifacts from the biometric signal.

According to some embodiments of the present invention, a device forsensing physiological and body motion information includes at least oneoptical emitter and at least one optical detector, and at least twooptical pathways. One optical pathway is configured to sense body motioninformation by sensing light from the at least one emitter scattered bybody motion. The other optical pathway is configured to sensephysiological information by sensing light from the at least one emitterscattered from the body by blood flow.

According to some embodiments of the present invention, a biometricsensor module includes a housing, a stabilizer member supported by thehousing, at least one optical emitter supported by the housing, and atleast one optical detector supported by the housing. The at least oneoptical emitter is configured to direct light into the body of thesubject via a first optical pathway and to direct light at thestabilizer member along a second optical pathway. The first and secondoptical pathways may be optically isolated from each other. The at leastone optical detector is configured to detect light from the body of thesubject and generate a first signal comprising subject physiologicalinformation, and is also configured to detect light reflected by thestabilizer member and generate a second signal comprising subject motioninformation. The sensor module may include at least one signal processorconfigured to process the first and second signals so as to removemotion artifacts from the first signal.

In some embodiments, the stabilizer member may include an optical filterthat is configured to pass, block, or scatter multiple differentwavelengths of light representative of subject motion. In otherembodiments, the at least one optical emitter may be configured todirect light into the body of the subject and/or at the stabilizermember in multiple different wavelengths.

In some embodiments, the at least one optical emitter includes a firstoptical emitter configured to direct light into the body of the subjectvia the first optical pathway, and a second optical emitter configuredto direct light at the stabilizer member along the second opticalpathway. The second optical emitter may include at least one opticalelement configured to direct light at the stabilizer member, such as alens, filter, and/or reflective element.

In some embodiments, the at least one optical detector includes a firstoptical detector configured to detect light from the body of the subjectand generate a first signal comprising subject physiologicalinformation, and a second optical detector configured to detectphysically modulated light reflected by the stabilizer member andgenerate a second signal comprising subject motion information. Thelight reflected by the stabilizer member is physically modulated due tosubject motion.

In some embodiments, the stabilizer member is movably supported by thehousing and includes a portion that extends from the housing and isconfigured to engage the body of the subject.

In some embodiments, the first optical pathway and/or the second opticalpathway comprises light guiding material.

In some embodiments, the housing comprises substantially opaquematerial.

In some embodiments, the sensor module is configured to be positioned ator within an ear of the subject. In other embodiments, the sensor moduleis configured to be secured to an appendage or other body location ofthe subject, or even integrated within clothing worn by the subject.

In some embodiments, the sensor module includes a blood flow stimulatorconfigured to increase blood perfusion at a location of the body of thesubject receiving light via the first optical pathway at or prior to thetime when the at least one optical detector detects light from the bodyand generates a physiological information signal.

According to other embodiments of the present invention, a sensor moduleconfigured to be worn by a subject includes a housing, at least oneoptical emitter supported by the housing, and at least one opticaldetector supported by the housing. The at least one optical emitter isconfigured to direct light into the body of the subject via a firstoptical pathway and to direct light at the body along a second pathway.The first and second optical pathways may be optically isolated fromeach other. The at least one optical detector is configured to detectlight from the body of the subject and generate a first signalcomprising subject physiological information, and wherein the at leastone optical detector is configured to detect light reflected by the bodyand generate a second signal comprising subject motion information. Thisreflected light may be physically modulated due to subject motion. Thesensor module may include at least one signal processor configured toprocess the first and second signals so as to remove motion artifactsfrom the first signal.

In some embodiments, the at least one optical emitter includes a firstoptical emitter configured to direct light into the body of the subjectvia the first optical pathway, and a second optical emitter configuredto direct light at the body along the second optical pathway.

In some embodiments, the at least one optical detector includes a firstoptical detector configured to detect light from the body of the subjectand generate a first signal comprising subject physiologicalinformation, and a second optical detector configured to detect lightreflected by the body and generate a second signal comprising subjectmotion information.

In some embodiments, the first optical pathway and/or the second opticalpathway comprises light guiding material.

In some embodiments, the housing comprises substantially opaquematerial.

In some embodiments, the at least one optical emitter is configured todirect light into the body of the subject and/or at the body of thesubject in multiple different wavelengths.

In some embodiments, the sensor module is configured to be positioned ator within an ear of the subject. In other embodiments, the sensor moduleis configured to be secured to an appendage or other body location of iothe subject, or even integrated within clothing worn by the subject.

In some embodiments, the sensor module includes a blood flow stimulatorconfigured to increase blood perfusion at a location of the body of thesubject receiving light via the first optical pathway at or prior to thetime when the at least one optical detector detects light from the bodyand generates a physiological information signal.

According to other embodiments of the present invention, a sensor moduleconfigured to be worn by a subject includes a housing, at least oneoptical emitter and at least one optical detector supported by thehousing, and a stabilizer member movably supported by the housing. Thestabilizer member includes a portion that extends through a firstaperture in the housing and is configured to engage the body of thesubject. The at least one optical emitter is configured to direct lightthrough a second aperture in the housing and into the body of thesubject via a first optical pathway and to direct light at a portion ofthe stabilizer member within the housing along a second optical pathway.The first and second optical pathways may be optically isolated fromeach other. The at least one optical detector is configured to detectlight from the body of the subject via a third aperture in the housingand generate a first signal comprising subject physiologicalinformation, and wherein the at least one optical detector is configuredto detect light reflected by the stabilizer member and generate a secondsignal comprising subject motion information. The sensor module mayinclude at least one signal processor configured to process the firstand second signals so as to remove motion artifacts from the firstsignal.

In some embodiments, the at least one optical emitter includes at leastone first optical emitter configured to direct light into the body ofthe subject via the first optical pathway, and at least one secondoptical emitter configured to direct light at the stabilizer memberalong the second optical pathway.

In some embodiments, a light guide is supported by the housing and theat least one optical emitter is configured to direct light into the bodyof the subject via the light guide. The light guide may include aplurality of portions that extend through respective apertures in thehousing and that are configured to engage portions of the body of thesubject.

In some embodiments, the housing is formed of substantially opaquematerial.

In some embodiments, the sensor module is configured to be positioned ator within an ear of the subject. In other embodiments, the sensor moduleis configured to be secured to an appendage or other body location ofthe subject, or even integrated within clothing worn by the subject.

In some embodiments, the sensor module includes a blood flow stimulatorconfigured to increase blood perfusion at a location of the body of thesubject receiving light via the first optical pathway at or prior to thetime when the at least one optical detector detects light from the bodyand generates a physiological information signal.

According to other embodiments of the present invention, a sensor moduleconfigured to be worn by a subject includes a housing, first and secondoptical emitters supported by the housing, an optical detector supportedby the housing, and first and second light guides supported by thehousing. The first light guide is in optical communication with thefirst optical emitter and defines a first optical pathway, and thesecond light guide is in optical communication with the second opticalemitter and defines a second optical pathway. The first and secondoptical pathways may be optically isolated from each other. The firstoptical emitter is configured to direct light into the body of thesubject via the first optical pathway, and the second optical emitter isconfigured to direct light at the body of the subject via the secondoptical pathway. The optical detector is configured to detect light fromthe body of the subject and generate a first signal comprising subjectphysiological information. The optical detector also is configured todetect light reflected by the body of the subject and generate a secondsignal comprising subject motion information. The light reflected by thebody may be physically modulated due to subject motion. The sensormodule may include at least one signal processor configured to processthe first and second signals so as to remove motion artifacts from thefirst signal.

In some embodiments, the first light guide includes a portion thatextends through an aperture in the housing and is configured to engagethe body of the subject.

In some embodiments, the housing is formed of substantially opaquematerial.

In some embodiments, the sensor module is configured to be positioned ator within an ear of the subject. In other embodiments, the sensor moduleis configured to be secured to an appendage or other body location ofthe subject, or even integrated within clothing worn by the subject.

In some embodiments, the sensor module includes a blood flow stimulatorconfigured to increase blood perfusion at a location of the body of thesubject receiving light via the first optical pathway at or prior to thetime when the optical detector detects light from the body and generatesa physiological information signal.

According to other embodiments of the present invention, a sensor moduleconfigured to be worn by a subject includes a housing, at least oneoptical detector supported by the housing, at least one optical emittersupported by the housing, and a stabilizer member movably supported bythe housing. The stabilizer member includes a portion that extends fromthe housing and engages the body of the subject. The at least oneoptical emitter is configured to direct light into the body of thesubject via a first optical pathway and to direct light at the at leastone optical detector along a second optical pathway. The first andsecond optical pathways typically are optically isolated from eachother. The stabilizer member is configured to modulate an amount oflight in the second optical pathway by modulating a volume of the secondoptical pathway.

The at least one optical detector is configured to detect light from thebody of the subject and generate a first signal containing subjectphysiological information. The at least one optical detector isconfigured to detect light in the second optical pathway and generate asecond signal containing subject motion information. The sensor modulemay include at least one signal processor configured to process thefirst and second signals so as to remove motion artifacts from the firstsignal.

In some embodiments, the first optical pathway and/or the second opticalpathway includes light guiding material.

In some embodiments, the second optical pathway includes a plurality oflight channels, and the stabilizer member is configured to modulate anamount of light in the second optical pathway responsive to subjectmotion by modulating a volume of the plurality of light channels.

In some embodiments, the housing comprises substantially opaquematerial.

In some embodiments, the sensor module is configured to be positioned ator within an ear of the subject. In other embodiments, the sensor moduleis configured to be secured to an appendage or other body location ofthe subject, or even integrated within clothing worn by the subject.

In some embodiments, the sensor module includes a blood flow stimulatorconfigured to increase blood perfusion at a location of the body of thesubject receiving light via the first optical pathway at or prior to thetime when the at least one optical detector detects light from the bodyand generates a physiological information signal.

According to other embodiments of the present invention, a sensor moduleconfigured to be worn by a subject includes a housing, a pressuretransducer supported by the housing, at least one optical emittersupported by the housing, at least one optical detector supported by thehousing, and a stabilizer member movably supported by the housing. Thestabilizer member is configured to modulate the pressure transducerresponsive to subject motion and includes a portion that extends fromthe housing and engages the body of the subject. The at least oneoptical emitter is configured to direct light into the body of thesubject. The at least one optical detector is configured to detect lightfrom the body of the subject and generate a first signal containingsubject physiological information. The pressure transducer is configuredto generate a second signal containing subject motion information. Thesensor module may include at least one signal processor configured toprocess the first and second signals so as to remove motion artifactsfrom the first signal.

In some embodiments, the sensor module is configured to be positioned ator within an ear of the subject. In other embodiments, the sensor moduleis configured to be secured to an appendage of the subject, or evenintegrated within clothing worn by the subject.

In some embodiments, the sensor module includes a blood flow stimulatorconfigured to increase blood perfusion at a location of the body of thesubject receiving light via the at least one optical emitter at or priorto the time when the at least one optical detector detects light fromthe body and generates a physiological information signal.

According to other embodiments of the present invention, a method ofremoving motion artifacts from a biometric signal generated by a sensormodule worn by a subject is provided. The sensor module includes astabilizer member, at least one optical emitter, and at least oneoptical detector. The method includes directing light from the at leastone optical emitter into the body of the subject via a first opticalpathway, directing light from the at least one optical emitter at thestabilizer member along a second optical pathway, detecting light fromthe body of the subject and generating a first signal comprising subjectphysiological information, detecting light reflected by the stabilizermember and generating a second signal comprising subject motioninformation, and processing the first and second signals so as to removemotion artifacts from the first signal.

In some embodiments, the at least one optical emitter includes first andsecond optical emitters, and the method includes directing light fromthe first optical emitter into the body of the subject via the firstoptical pathway, and directing light from the second optical emitter atthe stabilizer member along the second optical pathway.

In some embodiments, the at least one optical detector includes firstand second optical detectors, and the method includes detecting lightfrom the body of the subject and generating a first signal comprisingsubject physiological information via the first optical detector, anddetecting physically modulated light reflected by the stabilizer memberand generate a second signal comprising subject motion information viathe second optical detector.

In some embodiments, the first and second optical pathways are opticallyisolated from each other.

According to other embodiments of the present invention, a method ofremoving motion artifacts from a biometric signal generated by a sensormodule worn by a subject is provided. The sensor module includes atleast one optical emitter and at least one optical detector and themethod includes directing light from the at least one optical emitterinto the body of the subject via a first optical pathway and at the bodyof the subject along a second optical pathway, detecting light from thebody of the subject and generating a first signal containing subjectphysiological information, detecting light reflected by the body of thesubject and generating a second signal containing subject motioninformation, and processing the first and second signals so as to removemotion artifacts from the first signal.

In some embodiments, the at least one optical emitter includes first andsecond optical emitters, and the method includes directing light fromthe first optical emitter into the body of the subject via the firstoptical pathway, and directing light from the second optical emitter atthe body along the second optical pathway.

In some embodiments, the at least one optical detector includes firstand second optical detectors, and the method includes detecting lightfrom the body of the subject and generating a first signal containingsubject physiological information via the first optical detector, anddetecting light reflected by the body and generating a second signalcontaining subject motion information via the second optical detector.

In some embodiments, the first and second optical pathways are opticallyisolated from each other.

According to other embodiments of the present invention, a device, suchas a smartphone or other portable electronic device, includes a sensormodule configured to obtain physiological information from a bodylocation of a subject, and a blood flow stimulator configured toincrease blood perfusion at the body location at or prior to the timewhen the sensor module obtains the physiological information. The bloodflow stimulator may include a heater, such as an infrared (IR) heater,configured to increase blood perfusion. In some embodiments the bloodflow stimulator includes a mechanical actuator configured to applyphysical stimulation to the body location. For example, in someembodiments, the device is a smartphone, and the blood flow stimulatoris a vibration actuator within the smartphone configured to providehaptic feedback to a user.

In some embodiments, the sensor module includes a stabilizer member, atleast one optical emitter, and at least one optical detector. The atleast one optical emitter is configured to direct light into the body ofthe subject via a first optical pathway and to direct light at thestabilizer member along a second optical pathway. The at least oneoptical detector is configured to detect light from the body of thesubject and generate a first signal comprising subject physiologicalinformation, and to detect light reflected by the stabilizer member andgenerate a second signal comprising subject motion information.

In some embodiments, the sensor module includes at least one opticalemitter and at least one optical detector. The at least one opticalemitter is configured to direct light into the body of the subject via afirst optical pathway and to direct light at the body along a secondpathway. The at least one optical detector is configured to detect lightfrom the body of the subject and generate a first signal comprisingsubject physiological information, and to detect light reflected by thebody and generate a second signal comprising subject motion information.

According to other embodiments of the present invention, a wearabledevice includes an optical sensor that is configured to detect opticallyderived physiological information from a location on a body of asubject, and that includes at least one optical emitter and at least oneoptical detector. The wearable device also includes a thermal energygenerator configured to raise a temperature of the body at the location,a temperature sensor configured to sense body temperature information atthe location, and at least one circuit configured to control electricalbiasing of the at least one optical emitter, the thermal energygenerator, and the temperature sensor. In addition, the wearable deviceincludes data storage configured to receive and store data from theoptical sensor and temperature sensor, and a processor that isconfigured to process data in the data storage from the optical sensorin context with data in the data storage from the temperature sensor togenerate a physiological assessment for the subject.

In some embodiments, the at least one circuit is configured toelectrically bias the at least one optical emitter at set time periodsassociated with electrical biasing of the thermal energy generator.

In some embodiments, the at least one optical emitter includes aplurality of optical emitters, and the at least one circuit isconfigured to alternately bias the plurality of optical emitters in timeto generate a matrix of data including optical emitter wavelengthinformation and temperature information.

In some embodiments, the optical sensor is configured to sense scatteredlight and luminescent light from the location, and wherein the at leastone circuit is configured to alternately bias the plurality of opticalemitters in time to generate a matrix of data including optical emitterwavelength information, temperature information, and time information.

In some embodiments, the at least one optical detector includes aplurality of optical detectors, and at least one of the plurality ofoptical detectors is configured to detect at least one wavelength oflight that at least one other of the plurality of optical detectors isconfigured to not detect. Data from the plurality of optical detectorsis used to generate a matrix of data including optical emitterwavelength information and temperature information.

According to other embodiments of the present invention, a wearabledevice includes a sensor module, such as a PPG sensor module, that isconfigured to obtain physiological information from a body location of asubject wearing the device. The wearable device also includes a bladderof compliant material that contains a fluid, such as a liquid, gas orgel. The bladder is configured to contact the skin of the subject at oradjacent the body location. The bladder may have various shapes andconfigurations. In some embodiments, the bladder has a ring shape thatperipherally surrounds the sensor module.

A pressure sensor is provided that generates a signal proportional to achange in fluid pressure within the bladder. The change in pressure isresponsive to motion of the subject. As such, the pressure sensorgenerates a motion noise reference signal that can be used to removemotion artifacts from the physiological information obtained by thesensor module.

In some embodiments, the bladder is configured to at least partiallywrap around a limb of the subject.

In some embodiments, the bladder includes at least one fluid reservoircontaining a fluid and a plurality of artificial blood vessels in fluidcommunication with the at least one fluid reservoir. Compression of thebladder due to subject motion causes the fluid to be forced from the atleast one fluid reservoir into the artificial vessels, thereby creatingpressure within the bladder that can be detected by the pressure sensor.Such a configuration may be useful to more closely resemble that ofvenous blood in the body, such that the artificial structure maygenerate a motion noise waveform that more closely resembles that of thesubject's venous blood as it moves during motion, facilitating use as anoise reference as described above. It should be noted that the bloodvessels and reservoir may further comprise at least one air bubble (airpocket) to facilitate fluid flow during motion. In some embodiments, thedensity of air bubbles and the viscosity of blood may be engineered toclosely resemble that of the blood of the subject. In anotherembodiment, the fluid may comprise a plurality of fluids, each having adifferent density and/or polarity. Having such a distribution of fluidsmay more closely resemble the nature of the venous blood of the subject.

In some embodiments, the pressure sensor is a MEMS(micro-electromechanical systems) device, diaphragm, and/or actuator. Inother embodiments, the pressure sensor is an optomechanical pressuresensor.

It is noted that aspects of the invention described with respect to oneembodiment may be incorporated in a different embodiment although notspecifically described relative thereto. That is, all embodiments and/orfeatures of any embodiment can be combined in any way and/orcombination. Applicant reserves the right to change any originally filedclaim or file any new claim accordingly, including the right to be ableto amend any originally filed claim to depend from and/or incorporateany feature of any other claim although not originally claimed in thatmanner. These and other objects and/or aspects of the present inventionare explained in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which form a part of the specification,illustrate various embodiments of the present invention. The drawingsand description together serve to fully explain embodiments of thepresent invention.

FIGS. 1-2 illustrate “internal” optomechanical biometric sensor modulesand motion information and biometric information pathways generatedthereby, according to some embodiments of the present invention.

FIGS. 3-5 illustrate “external” optomechanical biometric sensor modulesand motion information and biometric information pathways generatedthereby, according to some embodiments of the present invention.

FIG. 6 illustrates an “internal” optomechanical biometric sensor moduleand motion information and biometric information pathways generatedthereby, according to some embodiments of the present invention.

FIG. 7A illustrates an “external” optomechanical biometric sensormodule, according to some embodiments of the present invention.

FIG. 7B is a top plan view of the sensor module of FIG. 7A.

FIG. 7C is a cross-sectional view of the sensor module of FIG. 7B takenalong lines 7C-7C in FIG. 7B.

FIG. 7D is a cross-sectional view of the sensor module of FIG. 7B takenalong lines 7D-7D in FIG. 7B.

FIGS. 8A-8B are exploded views of an internal optomechanical biometricsensor module, according to some embodiments of the present invention.

FIG. 9A is a front perspective view of the sensor module of FIGS. 8A-8Bin an assembled configuration.

FIG. 9B is a cross-sectional view of the sensor module of FIG. 9Aillustrating the biometric information pathways.

FIG. 9C is a cross-sectional view of the sensor module of FIG. 9Aillustrating the motion information pathways.

FIG. 9D is an enlarged cross-sectional view of the sensor module of FIG.9A illustrating the motion information pathways.

FIG. 10A illustrates an “internal” optomechanical biometric sensormodule, according to some embodiments of the present invention.

FIG. 10B is a cross-sectional view of the sensor module of FIG. 10Ataken along lines 10B-10B and illustrating the biometric informationpathways.

FIG. 10C is a cross-sectional view of the sensor module of FIG. 10Ataken along lines 10C-10C and illustrating the motion informationpathways.

FIG. 11A illustrates an “internal” optomechanical biometric sensormodule, according to some embodiments of the present invention.

FIG. 11B is a cross-sectional view of the sensor module of FIG. 11Ataken along lines 11B-11B and illustrating the biometric informationpathways.

FIG. 11C-11D are cross-sectional views of the sensor module of FIG. 11Ataken along lines 11C-11C and illustrating the motion informationpathways in an uncompressed and compressed configuration, respectively.

FIG. 12A illustrates an “internal” mechanical biometric sensor module,according to some embodiments of the present invention.

FIG. 12B is a cross-sectional view of the sensor module of FIG. 12Ataken along lines 12B-12B of FIG. 12A.

FIG. 12C is a cross-sectional view of the sensor module of FIG. 12Ataken along lines 12C-12C of FIG. 12A.

FIG. 13A illustrates a band for a wearable monitoring device having anintegrated pressure-sensing bladder, according to some embodiments ofthe present invention.

FIG. 13B is a top perspective view of a pressure-sensing bladder for awearable device, according to some embodiments of the present invention.

FIG. 13C is a top plan view of the pressure-sensing bladder of FIG. 13B.

FIG. 13D is a cross section view of the pressure-sensing bladder of FIG.13B and illustrating the bladder attached to a wristband of a wearabledevice.

FIG. 13E is a bottom plan view of the pressure-sensing bladder of FIG.13B.

FIG. 13F illustrates a pressure sensing bladder that includes fluidreservoirs and artificial blood vessels in fluid communication with thefluid reservoirs, according to some embodiments of the presentinvention.

FIGS. 14A-14B illustrate an array of optomechanical sensors secured toan arm of a subject and configured to track gestural motion, accordingto some embodiments of the present invention.

FIGS. 15A-15E are spectrograms of noise reference signals and associatedphotoplethysmograms.

FIGS. 16A-16C are spectrograms illustrating real time noise removal froma PPG signal.

FIG. 17 illustrates an optomechanical sensor module having a subtractivefilter and noise reference for removing noise from noisy physiologicalsignals, according to some embodiments of the present invention.

FIG. 18 is a flowchart of operations for utilizing the optomechanicalsensor of FIG. 17.

FIGS. 19-20 illustrate “internal” optomechanical biometric sensormodules, and motion information and biometric information pathwaysgenerated thereby, for “one-touch” or acute sensing applications,according to some embodiments of the present invention.

FIG. 21 illustrates an electronic device including a “one-touch” oracute sensing optomechanical sensor module, according to someembodiments of the present invention.

FIG. 22 is a cross-sectional view of the electronic device of FIG. 21,taken along line 22-22.

FIG. 23 is a flowchart of operations for implementing blood flow iostimulation to improve PPG measurements, according to some embodimentsof the present invention.

FIG. 24 is a top plan view of a device having an optomechanical sensormodule and blood flow stimulators, according to some embodiments of thepresent invention.

FIG. 25 is a cross-sectional view of an embodiment of the device of FIG.24, taken along line 25-25.

FIGS. 26A-26D illustrate an integrated micro-fabricated optomechanicalsensor module and processing steps for fabricating the optomechanicalsensor module, according to some embodiments of the present invention.

FIG. 27 illustrates a system for generating high-quality PPG data andcommunicating this data to a secondary device or system, according tosome embodiments of the present invention.

FIG. 28 is a cross-sectional view of an earpiece having multipleoptomechanical sensor modules integrated therein, according to someembodiments of the present invention.

FIG. 29 is a top plan view of a device having an optomechanical sensormodule and blood flow stimulators, according to some embodiments of thepresent invention.

FIGS. 30-32 are flowcharts of operations for generating physiologicalassessments of a subject, according to some embodiments of the presentinvention.

FIG. 33 is a graph of optical scatter (PPG) signal intensity andbioluminescence signal intensity vs. measured skin temperature formultiple optical excitation wavelengths, according to some embodimentsof the present invention.

FIG. 34 is a flowchart of operations for generating physiologicalassessments of a subject, according to some embodiments of the presentinvention.

DETAILED DESCRIPTION

The present invention will now be described more fully hereinafter withreference to the accompanying figures, in which embodiments of the toinvention are shown. This invention may, however, be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Like numbers refer to like elementsthroughout. In the figures, certain layers, components or features maybe exaggerated for clarity, and broken lines illustrate optionalfeatures or operations unless specified otherwise. In addition, thesequence of operations (or steps) is not limited to the order presentedin the figures and/or claims unless specifically indicated otherwise.Features described with respect to one figure or embodiment can beassociated with another embodiment or figure although not specificallydescribed or shown as such.

It will be understood that when a feature or element is referred to asbeing “on” another feature or element, it can be directly on the otherfeature or element or intervening features and/or elements may also bepresent. In contrast, when a feature or element is referred to as being“directly on” another feature or element, there are no interveningfeatures or elements present. It will also be understood that, when afeature or element is referred to as being “secured”, “connected”,“attached” or “coupled” to another feature or element, it can bedirectly secured, directly connected, attached or coupled to the otherfeature or element or intervening features or elements may be present.In contrast, when a feature or element is referred to as being “directlysecured”, “directly connected”, “directly attached” or “directlycoupled” to another feature or element, there are no interveningfeatures or elements present. Although described or shown with respectto one embodiment, the features and elements so described or shown canapply to other embodiments.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise.

As used herein, the terms “comprise”, “comprising”, “comprises”,“include”, “including”, “includes”, “have”, “has”, “having”, or variantsthereof are open-ended, and include one or more stated features,integers, elements, steps, components or functions but does not precludethe presence or addition of one or more other features, integers,elements, steps, components, functions or groups thereof. Furthermore,as used herein, the common abbreviation “e.g.”, io which derives fromthe Latin phrase “exempli gratia,” may be used to introduce or specify ageneral example or examples of a previously mentioned item, and is notintended to be limiting of such item. The common abbreviation “i.e.”,which derives from the Latin phrase “id est,” may be used to specify aparticular item from a more general recitation.

As used herein, the term “and/or” includes any and all combinations ofone or more of the associated listed items and may be abbreviated as“/”.

As used herein, phrases such as “between X and Y” and “between about Xand Y” should be interpreted to include X and Y. As used herein, phrasessuch as “between about X and Y” mean “between about X and about Y.” Asused herein, phrases such as “from about X to Y” mean “from about X toabout Y.”

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

It will be understood that although the terms first and second are usedherein to describe various features or elements, these features orelements should not be limited by these terms. These terms are only usedto distinguish one feature or element from another feature or element.Thus, a first feature or element discussed below could be termed asecond feature or element, and similarly, a second feature or elementdiscussed below could be termed a first feature or element withoutdeparting from the teachings of the present invention.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

The term “about”, as used herein with respect to a value or number,means that the value or number can vary more or less, for example by+/−20%, +/−10%, +/−5%, +/−1%, +/−0.5%, +/−0.1%, etc.

The term “circuit”, as used herein, refers to an entirely softwareembodiment or an embodiment combining software and hardware aspects,features and/or components (including, for example, a processor andsoftware associated therewith embedded therein and/or executable by, forprogrammatically directing and/or performing certain described actions,operations or method steps).

The term “photoplethysmography” (PPG), as used herein, refers to themethod generating optical plethysmogram information from at least oneregion of the body and processing this information to generate biometricinformation derived from the optical plethysmogram information. A PPGsensor module refers to a small module comprising at least one opticalemitter, at least one optical detector, and at least some signalprocessing electronics (analog and/or digital) to process the electricalsignal from the optical detector. The PPG sensor module may additionallycomprise optomechanics (optics and mechanical support) as well as anoise reference sensor, such as a motion sensor or the like, fordetecting motion noise information that can be processed along with theoptical detector information to attenuate motion artifacts from thedesired PPG signal. Other types of noise references, such asenvironmental light (ambient light) noise references may also beintegrated within the PPG sensor module to help attenuate ambient lightnoise from the desired PPG signal. When a plurality of optical emittersand/or detectors are integrated into the PPG sensor module, additionalbiometric information may be extracted, such as the determination ofblood analyte (blood constituent) levels (such as oxygenated hemoglobin,deoxygenated hemoglobin, carboxyhemoglobin, methemoglobin, bilirubin,and the like). PPG sensor modules may be placed or worn across virtuallyany part or region of the body having blood flow, but such modules maymore typically be proximal to the skin of an organism, such as the skinof the ear, forehead, nose, neck, chest, limbs (arms & legs), wrists,feet, digits (fingers & toes), or the like.

The term “metric”, as used herein, generally refers to a measurement ormeasurement system of a property, and a “sensor metric” refers to ameasurement or measurement system associated with a sensor. The metricmay comprise an identifier for a type of measurement, a value of themeasurement, and/or a diagnosis based on the measurement. For example, ametric may comprise “blood pressure”, with a value of “120/80”, and/or adiagnosis of “normal”.

The term “biometric”, as used herein, refers to a metric associated withphysiological (biological) information. Thus, the term “biometricsensor” and “physiological sensor” are synonymous. For example, a“biometric optical sensor” may refer to an optical sensor configured forphysiological monitoring. The “optical sensor” may refer to the opticaldetector itself or the complete PPG sensor comprising the opticalemitters, detectors, noise references, and the like.

The terms “sensor”, “sensing element”, “sensor module”, and “biometricsensor module”, as used herein, are interchangeable and refer to asensor element or group of sensor elements that may be utilized to senseinformation, such as information (e.g., physiological information, bodymotion, etc.) from the body of a subject and/or environmentalinformation in a vicinity of the subject. A sensor/sensingelement/sensor module may comprise one or more of the following: adetector element, an emitter element, a processing element, optics,mechanical support, supporting circuitry, and the like. Both a singlesensor element and a collection of sensor elements may be considered asensor, a sensing element, or a sensor module. Often times in thisdescription, the reference to a “sensor element” refers to a fundamentalcomponent of a sensor module or discrete sensor, wherein the sensormodule or discrete sensor comprises multiple sensor elements.

The term “optical emitter”, as used herein, may include a single opticalemitter and/or a plurality of separate optical emitters that areassociated with each other.

The term “optical detector”, as used herein, may include a singleoptical detector and/or a plurality of separate optical detectors thatare associated with each other.

The term “wearable sensor module”, as used herein, refers to a sensormodule configured to be worn on or near the body of a subject.

The terms “monitoring device” and “biometric monitoring device”, as usedherein, are interchangeable and include any type of device, article, orclothing that may be worn by and/or attached to a subject and thatincludes at least one sensor/sensing element/sensor module. Exemplarymonitoring devices may be embodied in an earpiece, a headpiece, a fingerclip, a digit (finger or toe) piece, a limb band (such as an arm band orleg band), an ankle band, a wrist band, a nose piece, a sensor patch,eyewear (such as glasses or shades), apparel (such as a shirt, hat,underwear, etc.), a mouthpiece or tooth piece, contact lenses, or thelike.

The term “monitoring” refers to the act of measuring, quantifying,qualifying, estimating, sensing, calculating, interpolating,extrapolating, inferring, deducing, or any combination of these actions.More generally, “monitoring” refers to a way of getting information viaone or more sensing elements. For example, “blood health monitoring”includes monitoring blood gas levels, blood hydration, andmetabolite/electrolyte levels.

The term “headset”, as used herein, is intended to include any type ofdevice or earpiece that may be attached to or near the ear (or ears) ofa user and may have various configurations, without limitation. Headsetsincorporating sensor modules, as described herein, may include monoheadsets (a device having only one earbud, one earpiece, etc.) andstereo headsets (a device having two earbuds, two earpieces, etc.), truewireless headsets (having two wireless earpieces), earbuds, hearingaids, ear jewelry, face masks, headbands, glasses or eyewear, and thelike. In some embodiments, the term “headset” may include broadlyheadset elements that are not located on the head but are associatedwith the headset. For example, in a “medallion” style wireless headset,where the medallion comprises the wireless electronics and theheadphones are plugged into or hard-wired into the medallion, thewearable is medallion would be considered part of the headset as awhole. Similarly, in some cases, if a mobile phone or other mobiledevice is intimately associated with a plugged-in headphone, then theterm “headset” may refer to the headphone-mobile device combination. Theterms “headset” and “earphone”, as used herein, are interchangeable.

The term “optomechanical”, as used herein, refers to optical modulationwith respect to mechanical energy in the general sense. The motion maybe due to relative motion, absolute motion, vibration, pressure, force,etc. For example, generally in these inventions, the optomechanicalsensor may be used to sense motion artifacts caused by any form ofmechanical energy.

The term “physiological” refers to matter or energy of or from the bodyof a creature (e.g., humans, animals, etc.). In embodiments of thepresent invention, the term “physiological” is intended to be usedbroadly, covering both physical and psychological matter and energy ofor from the body of a creature.

The term “body” refers to the body of a subject (human or animal) thatmay wear a monitoring device, according to embodiments of the presentinvention.

The term “processor” is used broadly to refer to a signal processor orcomputing system or processing or computing method which may belocalized or distributed. For example, a localized signal processor maycomprise one or more signal processors or processing methods localizedto a general location, such as to a wearable device. Examples of suchwearable devices may comprise an earpiece, a headpiece, a finger clip, adigit (finger or toe) piece, a limb band (such as an arm band or legband), an ankle band, a wrist band, a nose piece, a sensor patch,eyewear (such as glasses or shades), apparel (such as a shirt, hat,underwear, etc.), a mouthpiece or tooth piece, contact lenses, or thelike, as well as smartphones and other devices carried or worn by aperson. Examples of a distributed processor comprise “the cloud”, theinternet, a remote database, a remote processor computer, a plurality ofremote processors or computers in communication with each other, or thelike, or processing methods distributed amongst one or more of theseelements. The key difference is that a distributed processor may includedelocalized elements, whereas a localized processor may workindependently of a distributed processing system. As a specific example,microprocessors, microcontrollers, ASICs (application specificintegrated circuits), analog processing circuitry, or digital signalprocessors are a few non-limiting examples of physical signal processorsthat may be found in wearable devices.

The term “remote” does not necessarily mean that a remote device is awireless device or that it is a long distance away from a device incommunication therewith. Rather, the term “remote” is intended toreference a device or system that is distinct from another device orsystem or that is not substantially reliant on another device or systemfor core functionality. For example, a computer wired to a wearabledevice may be considered a remote device, as the two devices aredistinct and/or not substantially reliant on each other for corefunctionality. Notwithstanding the foregoing, any wireless device (suchas a portable device, for example) or system (such as a remote databasefor example) is considered remote to any other wireless device orsystem.

The terms “respiration rate” and “breathing rate”, as used herein, areinterchangeable.

The terms “heart rate” and “pulse rate”, as used herein, areinterchangeable.

The term “RRi” refers to “R-R interval” in a cardiac waveform (i.e., anelectrocardiogram, photoplethysmogram, or the like) of a person.Generally, where heart rate is used in embodiments of the presentinvention, RRi may also be applied in a similar manner. However, RRi andheart rate are generally related in an inverse fashion, such that1/RRi=instantaneous heart rate.

The term “thermal communication”, as used herein, includes one or moreof conductive transfer of thermal energy, convective transfer of thermalenergy, and radiative transfer of thermal energy.

Various biometric parameters and activity parameters may be describedherein by using the name of the parameter (such as “heart rate”, VO₂max,and the like). Generally speaking, these names may refer toinstantaneous values, averaged values, or some other processing of theassociated parameter(s). For example, a breathing rate of 14 BPM(breaths per minute) may refer to an instantaneous measurement or anaveraged measurement (for example, an average breathing rate of 14 BPMas averaged over 5 minutes). Unless “instantaneous”, “average”, or someother adjective is used to describe the parameter, it should not beassumed that there is a limitation with respect to the processing of theparameter.

In the following figures, various monitoring devices will be illustratedand described for attachment to the ear or an appendage of the humanbody, or even integrated within clothing. However, it is to beunderstood that embodiments of the present invention are not limited tothose worn by humans. In addition, monitoring devices according toembodiments of the present invention may be worn at other locations ofthe body.

The ear is an ideal location for wearable health and environmentalmonitors. The ear is a relatively immobile platform that does notobstruct a person's movement or vision. Monitoring devices located at anear have, for example, access to the inner-ear canal and tympanicmembrane (for measuring core body temperature), muscle tissue (formonitoring muscle tension), the pinna, earlobe, and elsewhere (formonitoring blood gas levels), the region behind the ear (for measuringskin temperature and galvanic skin response), and the internal carotidartery (for measuring cardiopulmonary functioning), etc. The ear is alsoat or near the point of exposure to: environmental breathable toxicantsof interest (volatile organic compounds, pollution, etc.); noisepollution experienced by the ear; and lighting conditions for the eye.Furthermore, as the ear canal is naturally designed for transmittingacoustical energy, the ear provides a good location for monitoringinternal sounds, such as heartbeat, breathing rate, and mouth motion.Accurate sensing of photoplethysmograms and heart rate from the ear hasbeen demonstrated in regions between the concha and anti-traguslocations of the outer ear, and elsewhere at the ear.

Optical coupling into the blood vessels of the ear may vary betweenindividuals. As used herein, the term “coupling” refers to theinteraction or communication between excitation energy (such as light)entering or exiting a region and the region itself. For example, oneform of optical coupling may be the interaction between excitation lightgenerated from within an optical sensor of an earbud (or other devicepositioned at or within an ear) and the blood vessels of the ear. In oneembodiment, this interaction may involve excitation light entering theear region and scattering from a blood vessel in the ear such that thetemporal change in intensity of scattered light is proportional to atemporal change in blood flow within the blood vessel. Another form ofoptical coupling may be the interaction between excitation lightgenerated by an optical emitter within an earbud and a light-guidingregion of the earbud. Thus, an earbud with integrated light-guidingcapabilities, wherein light can be guided to multiple and/or selectregions along the earbud, can assure that each individual wearing theearbud will generate an optical signal related to blood flow through theblood vessels. Optical coupling of light to a particular ear region ofone person may not yield photoplethysmographic signals for each person.Therefore, coupling light to multiple regions may assure that at leastone blood-vessel-rich region will be interrogated for each personwearing an earbud. Coupling multiple regions of the ear to light mayalso be accomplished by diffusing light from a light source within anearbud.

Another example of optical coupling is the coupling of scattered lightfrom the body of a subject to light-guiding optics that guide lighttowards a photodetector. The term “coupling”, however, may also refer tomechanical coupling, electrical coupling, optomechanical coupling, orthe like, and not just optical coupling. As an example of optomechanicalcoupling, the optical coupling of a light guide from an optical emitterto the body of a subject may also be associated with the mechanicalcoupling of the light guide (or of another optical pathway) to the bodyof a subject.

Referring to FIGS. 1-6, biometric sensor modules 10 that may beincorporated into various wearable devices are illustrated. Theillustrated sensor modules 10 may be integrated into various wearabledevices/apparel including, but not limited to, an earbud, a wristband,an armband, a smartphone, clothing and accessory apparel, or any otherwearable form-factor for a digit, limb, torso, head, ear, face, and thelike. Each sensor module 10 is configured to capture motion informationfrom the body of a subject via optomechanical coupling between the bodyand the sensor module 10. The captured motion information serves as anoise reference for filtering motion noise (motion artifacts) frombiometric sensor signals. In the embodiment illustrated in FIG. 1, asensor module (e.g., a PPG sensor module, etc.) 10 includes a base 12,such as a printed circuit board (PCB), that supports first and secondoptical emitters 14, 16, and an optical detector 18. An optical barrier20 is provided to prevent light emitted by the emitter 16 from directlyentering or saturating the optical detector 18. The illustrated sensormodule 10 also includes a stabilizer member 22 that is configured totransfer motion information from the body of a subject wearing thesensor module 10 to the optical detector 18. The stabilizer member 22may also be referred to as a light modulating (or light regulating)mechanism. In addition to helping transfer subject motion informationcaused by mechanical energy (i.e., the force of the subject body againstthe stabilizer member 22 as a result of subject motion), the stabilizermember 22 may also be configured to help stabilize the sensor module 10against the skin.

The physical dimensions of the biometric sensor modules of FIGS. 1-6 aresuch that they are small enough to be wearable but large enough tosupport the optics, electronics, and powering components. Considering atop-view, typical dimensions for the modules may be on the order of ˜1mm-20 mm in length/diameter and the associated optics may be on theorder of 100 microns-3 mm in length diameter. However, smaller andlarger sizes may be utilized, and embodiments of the present inventionare not limited to any particular sizes or dimensions.

The illustrated sensor module 10 produces two optical pathways 30, 40.The first optical pathway 30 (also referred to as the “motioninformation pathway”) is created by light emitted by the first opticalemitter 12 and reflected off of the stabilizer member 22. The secondpathway 40 (also referred to as the “biometric information pathway”) iscreated by light emitted by the second optical emitter 16 that isabsorbed, scattered, and/or reflected by tissue, blood vessels, etc.,within the body of the subject. The biometric information pathway 40contains a higher level of subject physiological information than themotion information pathway 30, which contains a higher level of subjectmotion information.

The embodiment illustrated in FIG. 2 is similar to the embodiment ofFIG. 1 except that a single optical emitter is utilized to create boththe motion information optical pathway 30 and the biometric informationoptical pathway 40. The illustrated sensor module (e.g., a PPG sensormodule, etc.) 10 includes a base 12, such as a PCB, an optical emitter14, first and second optical detectors 18, 24, and an optical barrier20. As discussed above, the optical barrier 20 is configured to preventlight emitted by the emitter 14 from directly entering/saturating theoptical detector 18. The illustrated sensor module 10 also includes astabilizer member 22 that is configured to transfer motion informationfrom the body of a subject wearing the biometric sensor module 10, aswell as stabilize the biometric monitor 10 relative to the skin of thesubject. As with the embodiment of FIG. 1, the illustrated sensor module10 produces a motion information pathway 30 and a biometric informationpathway 40. The emitter 14 is configured to direct light towards thestabilizer member 22 to create the motion information pathway 30 and isalso configured to direct light towards the skin of the subject suchthat the light can be absorbed, scattered, and/or reflected by tissue,blood vessels, etc., within the body of the subject.

The embodiment illustrated in FIG. 3 is similar to the embodiment ofFIG. 1 except that a stabilizer member is not utilized. The illustratedsensor module (e.g., a PPG sensor module, etc.) 10 includes a base 12,such as a PCB, supporting first and second optical emitters 14, 16, andoptical detector 18, and an optical barrier 20. As discussed above, theoptical barrier 20 is configured to prevent light emitted by the emitter16 from directly entering/saturating the optical detector 18. As withthe embodiment of FIG. 1, the illustrated sensor module 10 produces amotion information optical pathway 30 and a biometric informationoptical pathway 40. However, the motion information pathway 30 iscreated by the first emitter 14 directing light towards the subject sothat the light reflects directly off of the skin, without substantialinteraction with blood flow-rich tissue, and is detected by the opticaldetector 18.

The embodiment illustrated in FIG. 4 is similar to the embodiment ofFIG. 2 except that a stabilizer member is not utilized. The illustratedsensor module (e.g., a PPG sensor module, etc.) 10 includes a base 12,such as a PCB, supporting an optical emitter 14, first and secondoptical detectors 18, 24, and an optical barrier 20. As discussed above,the optical barrier 20 is configured to prevent light emitted by theemitter 16 from directly entering/saturating the optical detector 18. Aswith the embodiment of FIG. 2, the illustrated sensor module 10 producesa motion information optical pathway 30 and a biometric informationoptical pathway 40. However, the motion information pathway 30 iscreated by the emitter 14 directing light towards the subject so thatthe light reflects directly off of the skin, without substantialinteraction with blood flow-rich tissue, and is detected by the opticaldetector 18. The single emitter 14 is also configured to direct lighttowards the skin of the subject such that the light can be absorbed,scattered, and/or reflected by tissue, blood vessels, etc., within theskin of the subject.

The sensor modules illustrated in FIGS. 1 and 2 are referred to as“internal” optomechanical sensor modules (because the motion pathwaymodulation happens via an internal motion, i.e., the stabilizer membermotion), and the sensor modules of FIGS. 3 and 4 are referred to as“external” optomechanical sensor modules (because the motion pathwaymodulation happens via an external motion, i.e., motion between the skinand the body). Each of the embodiments illustrated in FIGS. 1-4 work byphysically modulating light in response to motion between the body ofthe subject wearing the sensor module 10 and the sensor module 10. InFIGS. 1 and 2, the stabilizer member 22 is used to transfer motioninformation from the body of the subject via the motion informationpathway 30. In contrast, for the “external” embodiments of FIGS. 3 and4, physical modulation is achieved by relative motion between the bodyof the subject and the biometric sensor module 10, itself.

In each of the embodiments of FIGS. 1-4, the motion information pathway30 contains little or no physiological information. As such, byprocessing the two separate signals created by the two optical pathways(i.e., the motion information pathway 30 and the biometric informationpathway 40) via a circuit or processor, motion noise information may beattenuated and the biometric signal information may be preserved oramplified. In some embodiments, the attenuation of motion artifacts, byprocessing the two separate signals, may be executed in analog space(via analog comparator methods, differential amplification, analogadaptive filtering, or the like) or in digital space (via spectralsubtraction, digital adaptive filtering, variable filtering, or thelike).

For embodiments as illustrated in FIGS. 1-4, it should be noted that,because the signal pathways for biometrics 40 and motion 30 aredistinct, modulation of the electrical power feeding the opticalemitter(s) is not critical for embodiments of the present invention tooperate. Thus, embodiments of the present invention may work duringsteady state (DC) powering conditions without modulating power to theoptical emitter or detector. However, modulating the optical emitters isindeed permitted in these configurations and may be useful for digitalsignal processing (in general) and for removing ambient light noise. Asa specific example, ambient light may be attenuated from a PPG signaloutput by subtracting optical detector signals collected when theoptical emitter is shut off from optical detector signals collected whenthe optical emitter is turned on. As another example, for theembodiments having at least two optical emitters (such as illustrated inFIGS. 1 and 3), the emitters may be modulated in an alternating fashion,where only one emitter is generating light at a given time. This mayhelp prevent optical cross-talk from contaminating the optical detectorreadings when assessing the biometric signal pathway 40 vs. the motionsignal pathway 30.

Referring to FIG. 5, an external optomechanical sensor module (e.g., aPPG sensor module, etc.) 10, according to other embodiments of thepresent invention, is illustrated. The illustrated sensor module 10 maybe integrated into various wearable devices including, but not limitedto, an earbud, a wristband, an armband, a smartphone, or any wearableform-factor for a digit, limb, torso, head, ear, face, and the like. Theembodiment illustrated in FIG. 5 is similar to the embodiment of FIG. 3except that various optical elements (e.g., an optical filter, anoptical lens, etc.) are utilized with the optical emitters 14, 16, andwith the detector 18. For example, one or more optical elements 15 areassociated with the emitter 14 to help steer light so as to be reflectedfrom the skin of the user to generate the motion information opticalpathway 30. One or more optical elements 17 are associated with theemitter 17 to help steer light so as to enter the skin of the subjectand to generate the biometric information optical pathway 40. One ormore optical elements 19 are associated with the optical detector andfacilitate detection of the light from each of the motion informationpathway 30 and the biometric information pathway 40. Examples ofsuitable optical elements include light guides, light reflectors, lightcladding, or the like. In the illustrated embodiment, a barrier 20 ispositioned between the detector 18 and each of the emitters 14, 16, andeach barrier 20 is configured to prevent light emitted by the emitters14, 16 from directly entering/saturating the optical detector 18.

It should be noted that a combined external and internal optomechanicalsensor module may also be produced by combining external pathwaycomponents and internal pathway components on the same module. In suchcase, it may be preferable to have at least one optical detectorassociated with each pathway, such that at least one detector isassociated with the external pathway and at least one detector isassociated with the internal pathway. Alternatively, one detector may beused by alternately powering the emitters associated with each pathway,such that a single emitter (or multiple emitters) from only one pathwayis powered on at any given time.

In other embodiments of the present invention, as illustrated in FIG. 6,an internal optomechanical sensor module 10 may generate both a motionsensing pathway 30 and a biometric signal pathway 40 via a singleoptical emitter 14 and a single optical detector 18. The illustratedsensor module 10 may be integrated into various wearable devicesincluding, but not limited to, an earbud, a wristband, an armband, asmartphone, or any wearable form-factor for a digit, limb, torso, head,ear, face, and the like. A stabilizer member 26 incorporates one or moreoptical filters to pass, block, or scatter distinguishable wavelengthsor wavelength bands. For example, some optical wavelengths from theoptical emitter 14 may pass through the stabilizer member 26 and passthrough the biometric signal pathway 40, whereas other opticalwavelengths may be scattered by the stabilizer member 26 and passthrough the motion sensing pathway.

In the illustrated embodiment, the optical emitter 14 is configured togenerate at least two distinguishable wavelengths of electromagneticenergy at distinguishably separate time periods, and/or the opticaldetector 18 is configured to discriminate between at least twodistinguishable wavelengths. For example, the optical emitter 14 maycomprise at least two separate emitters (such as with an LED array ormesa array, etc.) which alternate emission intensity in time, and thedetector 18 may be configured to sense each wavelength separately intime. As another example, the optical emitter 14 may be configured togenerate multiple wavelengths simultaneously (i.e., not alternating intime), and the detector 18 may comprise at least two distinct detectingregions (such as photodiodes or mesa arrays, etc.) each associated witha different optical filter, such that the detector 18 can sense eachwavelength simultaneously via a separate detecting region or “channel”.An important benefit of the internal optomechanical sensor configurationof FIG. 6 is that a single optical emitter and single optical detectormay be used, unlike the embodiments presented in FIG. 1 and FIG. 2.

Referring now to FIGS. 7A-7D, an “external” optomechanical sensor module(e.g., a PPG sensor module, etc.) 100 that can generate both a motioninformation optical pathway 30 and a biometric information opticalpathway 40, io according to some embodiments of the present invention,is illustrated. The illustrated biometric sensor module 100 may beintegrated into various wearable devices including, but not limited to,an earbud, a wristband, an armband, a smartphone or any wearableform-factor for a digit, limb, torso, head, ear, face, and the like. Theillustrated sensor module 100 includes a housing 102 with a generallyrectangular configuration. However, embodiments of the present inventionare not limited to the illustrated configuration of the biometric sensormodule 100. The sensor module 100 may have any shape, such astriangular, polygonal, round, etc. The housing 102 may be formed ofsubstantially opaque material.

The size of the sensor module 100 may be determined in part by thelocation of the body where the sensor module 100 is positioned. Forexample, a smaller sensor module 100 may be better suited for the ear oralong a muscle group, whereas a larger sensor module 100 may be bettersuited for a flat surface, such as the wrist or forearm, etc. However,the sensor module 100 should ideally be configured to be small enough tonot “rock” on multiple muscle groups as they independently flex.

Within the sensor module housing 102 is a base 110, such as a PCB, thatsupports a first pair of optical emitters 112, a second pair of opticalemitters 114, and an optical detector 116. Exemplary optical emitters112, 114 include, but are not limited to light-emitting diodes (LEDs),laser diodes (LDs), compact incandescent bulbs, organic LEDs (OLEDs),micro-plasma emitters, IR blackbody sources, or the like. A light guide120 is in optical communication with each optical emitter 112 and isshaped and configured to direct light emitted from each emitter 112 intothe skin of a subject wearing the sensor module 100 so as to generate abiometric information pathway 40 (FIG. 7D). A light guide 130 is inoptical communication with each optical emitter 114 and is shaped andconfigured to direct light so as to be reflected off of the skin of thesubject and to create a motion information pathway 30 (FIG. 7D).

A light guide 140 is in optical communication with the detector 114 andis configured to collect light from both the motion information pathway30 and the biometric information pathway 40 and deliver collected lightto the optical detector 114. In some embodiments, the light guide 140may include reflective material along the sidewalls thereof tofacilitate directing light to the optical detector. In addition, thelight guide 140 may have various shapes and configurations that can beused to collect light for detection.

The illustrated sensor module 100 also includes a plurality ofstabilizer members 150 that are configured to stabilize the sensormodule 100 when in contact with the skin of a subject. The light guides120, 130, the detector light guide 140, and the plurality of stabilizermembers 150 extend outwardly from the housing 102 through respectiveapertures formed within the outer surface 104 of the housing 102, asillustrated. It should be noted that, in this particular embodiment, thestabilizer members 150 are not configured to modulate a motion pathway.Namely, these stabilizers 150 are used solely for stabilizing the sensormodule 100 against the body of the subject.

In use, the sensor module 100 is positioned against the skin of asubject, for example via a strap or band, and optical emitters 112 emitlight through light guides 120 and into the body. The light propagatesthrough the body and then enters the light guide 140 that directs thelight to the light detector 116. Optical emitters 114 emit light throughlight guides 130 which direct the light to reflect off of the body ofthe subject and enter the light guide 140 so as to be detected by thedetector 116 and substantially without entering the body. Light from theoptical emitters 112 is turned on (modulated) at different times fromlight from the optical emitters 114 and the detector 116 is able todiscriminate light containing biometric information (i.e., light in thebiometric information pathway 40) from light containing motioninformation (i.e., light in the motion information pathway 30). Signalsgenerated by the light detector 116 for detected light containing motioninformation and detected light containing biometric information are sentto a processor and, together with any other reference signals, used toextract purely biometric information.

In one mode of operation, the emitters 112, 114 may be alternatelymodulated in time, such as with pulsing or biasing, such that signalprocessing can be used to identify motion information in the motioninformation pathway 30 and biometric information in the biometricinformation pathway 40. Then, an analog or digital filter may beimplemented to process both the motion information and biometricinformation to selectively attenuate motion artifact information fromthe biometric information.

Light in the motion information pathway 30 is modulated mostly by motionartifacts, such as optical scatter from the skin interface, as thesensor module housing 102 moves up and down and side-to-side against theskin of the subject wearing the sensor module 100. In contrast, light inthe biometric information pathway may be both physically modulated bysubject motion and physiologically modulated by being absorbed,scattered, and/or reflected by tissue, blood vessels, etc., within thebody of the subject.

In some embodiments, the optical emitters 114 may emit light at ashorter wavelength than light emitted by the optical emitters 112.Shorter wavelength light may not penetrate as deeply into the skin aslonger wavelength light, thereby reducing the intensity of biometricinformation in the motion information pathway 30. In some embodiments,optical emitters 114 emit light at optical wavelengths shorter than 470nm. In other embodiments, optical emitters 114 emit light at opticalwavelengths shorter than 420 nm. However, optical emitters that can emitlight at any optical wavelength can be used for the emitters 114,including wavelengths longer than that generated by the optical emitters112 in the biometric signal pathway. However, wavelengths shorter than280 nanometers and longer than 5 microns may be more challenging toeffectively implement partly due to high absorption of the shorterwavelengths and waveguiding effects at larger wavelengths. Moreover,solid state optical detectors may exhibit extremely low sensitivity forwavelengths shorter than 280 nanometers and may be extremely noisy(especially at room temperature and higher) for wavelengths greater than2 microns.

As discussed above, some biometric information (e.g., PPG information)may be included in the motion information pathway 30 because at leastsome light may interact with blood flow at the skin surface. As a resultscattered light received by the detector 116 may at least partiallycomprise biometric information, which is undesirable, as in such case itmay be difficult to use the motion pathway signal as a noise referencefor cleaning up a photoplethysmogram. Thus, in some embodiments of thepresent invention, the light guides 130 are configured such that lightemitted by the optical emitters 114 is steered to scatter from the skinat large angles which may discourage absorption at the skin. Asillustrated in FIG. 7D, the senor module 100 is configured such thatlight scatters from light guide 130 to propagate towards the skin at alarge angle and scatter off and/or guide along the skin surface towardsio the detector light guide 140.

Referring now to FIGS. 8A-8B and FIGS. 9A-9D, an “internal”optomechanical sensor module (e.g., a PPG sensor module, etc.) 200 thatcan generate both a motion information optical pathway 30 and abiometric information optical pathway 40, according to some embodimentsof the present invention, is illustrated. The illustrated biometricsensor module 200 may be integrated into various wearable devicesincluding, but not limited to, an earbud, a wristband, an armband, asmartphone or any wearable form-factor for a digit, limb, torso, head,ear, face, and the like. The illustrated sensor module 200 includes ahousing 202 having first and second portions 204, 206 that are securedtogether via fasteners F. In the illustrated embodiment, each fastener Fis a screw or other threaded member that is inserted through the housingsecond portion 206 and threadingly engages a threaded insert 207 securedto the first housing portion 204. However, embodiments of the presentinvention are not limited to the use of threaded fasteners. Various waysmay be utilized to secure the housing first and second portions 204, 206together, as would be understood by one skilled in the art. In someembodiments, one or both of the housing first and second portions 204,206 are formed of substantially opaque material to help prevent ambientlight intrusion and hence optical signal corruption.

The illustrated sensor module 200 has a generally round configuration.However, embodiments of the present invention are not limited to theillustrated configuration of the sensor module 200. The sensor module200 may have any shape, such as triangular, polygonal, rectangular, etc.In addition, the size of the sensor module 200 may be determined in partby the location of the body where the sensor module 200 is positioned.For example, a smaller sensor module 200 may be better suited for theear or along a muscle group, whereas a larger sensor module 100 may bebetter suited for a flat surface, such as the wrist or forearm. However,the sensor module 200 should ideally be small enough to not “rock” onmultiple muscle groups as they independently flex.

Positioned within the housing 202 of the sensor module 200 is a base210, such as a PCB, that supports optical emitters 212, 214 and opticaldetector 216. Also positioned within the housing 202 is a light guide220 that is configured to be in optical communication with opticalemitters 212, a stabilizer pad 230, and a light guide 240 that isconfigured to be in optical communication io with the optical detector216.

The illustrated light guide 220 includes a plurality of elements 222extending outwardly from one side thereof that are configured to extendthrough respective apertures 203 in the first housing portion 204. Theseelements 222 are not meant to transfer motion information, unlikestabilizing members 232 and 234, but rather are used for stabilizing(supporting) the sensor at the body.

The light guide 220 also includes elements 224 that extend throughapertures 205 in the first housing portion 204 that are configured toguide light from emitters 212 into the body of a subject wearing thesensor module 200. The light guide 220 is also configured to internallyguide light from the emitters 214 towards the stabilizer members 232,234 of the stabilizer pad 230.

The illustrated stabilizer pad 230 includes a first pair of stabilizermembers 232 extending outwardly therefrom that are configured to extendthrough respective apertures 207 in the first housing portion 204. Theillustrated stabilizer pad 230 also includes two pair of stabilizermembers 234 extending outwardly therefrom that are configured to extendthrough respective apertures 209 in the first housing portion 204. Thestabilizer members 232, 234 are configured to contact the skin of asubject and move in response to subject motion. Light from the opticalemitters 214 is directed towards the stabilizer members 232, 234 viaeither the light guide 220 or via an empty pocket in the pad 230 inorder to create respective motion information pathways 30, as will bedescribed below.

In the illustrated embodiment, the light guide 220 and stabilizer pad230 are integrated as one unit and referred to as a “multi-shot” lens.The illustrated multi-shot lens may be fabricated by directing two typesof plastic into a mold (transparent+opaque), such that there are noseams between the two regions. As a result, the multi-shot lens canprevent the leakage of moisture, such as sweat from a subject wearingthe sensor module 200, into the electronics. The transparent portion ofthe lens is configured for light guiding. The opaque region isconfigured for optomechanical sensing (i.e., motion sensing) asdescribed above. However, in other embodiments, the light guide 220 andstabilizer pad 230 may be separate elements.

Referring now to FIG. 9A, the sensor module 200 of FIGS. 8A-8B isillustrated in an assembled configuration. The stabilizer members 232,234 extend through the housing first portion, as illustrated. Thestabilizer members 232, 234 interact with the skin of a subject wearingthe sensor module 200 and are configured to compress downwardly againstthe light guide 220 as a result of subject motion and modulate lightemitted by optical emitters 214 to produce motion information opticalpathways (e.g., 30, FIGS. 1-2) that are detected by the optical detector216. The stabilizer members 232, 234 are configured to change shape(i.e., collapse) in proportion to relative motion between the skin andthe sensor module 200. For example, this relative motion may be causedby force applied upon the stabilizer members 232, 234 by the body of theuser. When a stabilizer member 232, 234 collapses, it may modulate lightbetween the optomechanical emitters 214 and the detector 216 inproportion to this relative motion. Thus, whereas the externaloptomechanical sensor light guides 120, 130 of the sensor module ofFIGS. 7A-7D may be made of rigid optically transparent material, so thatbending of the optics will not distort the desired reflection profile ofscattered light, in contrast, the internal optomechanical sensor module200 utilizes stabilizer members 232, 234 that are made of material thatis at least partially compliant (pliable) upon a pressure between thesensor module 200 and the skin/body.

FIG. 9B is a cross-sectional view of the sensor module 200 of FIG. 9Aand illustrates the configuration of the light guide 220 that createsthe biometric information optical pathway that allows light emitted fromthe optical emitters 212 to enter the body of the subject and then becollected and detected by the detector 216. FIG. 9C is a cross-sectionalview of the sensor module 200 of FIG. 9A and that illustrates theconfiguration of the light guide 220 that creates the motion informationoptical pathways that allows light emitted from the optical emitters 214to be modulated by the stabilizer members 232, 234 and then be detectedby the detector 216. Motion information pathways 30 produced by thesensor module 200 are illustrated in FIG. 9D.

During relative motion between the sensor module 200 and the body of asubject wearing the sensor module, light scattered via the motioninformation pathways and light scattered by the biometric informationpathways may both comprise motion artifact information. The linearity ofmotion artifact information from these optical pathways may be at leastpartially determined by the compliance of the stabilizer members 232,234 used. Generally, a higher linearity between these pathways may berealized when the compliance of the stabilizer members 232, 234 is closeto that of the skin of the subject. This is because light scattered froma biometric information pathway may be scattered mostly by the skinand/or other tissue near the skin of the user, and thus stabilizermembers 232, 234 having a mechanical compliance similar with that ofskin may also scatter light in a similar manner during motion. It shouldbe noted that although the motion information pathways 30 in FIG. 9D donot contain any light guiding material (e.g., they are filled with airor a vacuum), the motion information pathways may be filled with lightguiding material instead. Moreover, this light-guiding material may alsobe rigid (such as glass) or compliant (such as silicone).

For the embodiments illustrated in FIGS. 1-6, 7A-7D, 8A-8B and 9A-9D,physical dimensions of housings for these embodiments may be on theorder of about 5-20 millimeters, and the physical dimensions of theoptical emitter and detector components may be on the order of 0.5-3 mm.However, embodiments of the present invention are not limited to anyparticular housing size/configuration or optical emitter/detectorsize/configuration. Numerous size configurations are suitable forembodiments of the present invention. Some size limitations of note arethat the ideal spacing between emitters and detectors in a biometricsignal pathway may be in between 2 mm and 7 mm. Generally speaking, thefarther the emitter-to-detector spacing, the higher the signal-to-noise(AC/DC) ratio. However, if the spacing is too far, the biometric signalwill be too weak to be above the noise floor of the photodetector. Also,the sizing of optics in the embodiments of FIGS. 1-6, 7A-7D, 8A-8B and9A-9D may ideally be larger than a few tens of microns, so that theoptics can capture enough light and not overly attenuate signals.

Referring now to FIGS. 10A-10C, an internal optomechanical sensor module(e.g., a PPG sensor module, etc.) 300, according to other embodiments ofthe present invention, is illustrated. The illustrated sensor module 300includes a light guide 320 having three separate portions 320 a, 320 b,320 c separated by optical barriers 330. FIG. 10B is a cross-sectionalview of the sensor module 300 of FIG. 10A taken along lines 10B-10B andillustrates the biometric information pathways 40. The light guide 320is configured to allow light emitted from the optical emitters 312 toenter the body of the subject and then be collected and io detected bythe detector 316 in order to create biometric information pathways.

FIG. 10C is a cross-sectional view of the sensor module 300 of FIG. 10Ataken along lines 10C-10C and illustrates the motion informationpathways 30. Stabilizer members 332 are configured to modulate withmotion at the sensor module/skin interface. As the interface forceincreases on a stabilizer member 332, the gap decreases thereby reducingthe amount of light reaching the optical detector 316. The modulation ofthe amount of light reaching the optical detector 316 can be correlatedto subject motion and a motion reference signal can be generated via aprocessor.

Referring now to FIGS. 11A-11D, an internal optomechanical sensor module(e.g., a PPG sensor module, etc.) 400, according to other embodiments ofthe present invention, is illustrated. The illustrated sensor module 400includes a base 410, such as a printed circuit board (PCB), supporting apair of optical emitters 412 and an optical detector 416. The sensormodule 400 also includes a compressible/deformable member 420 thatcontains a plurality of internal light-shuttering channels or pathways422. In FIG. 11C, there is only a light external pressure on thecompressible/deformable member 420 of the sensor module 400. As aresult, the light-shuttering pathways 422 remain expanded allowing amaximum amount of light therethrough to the optical detector 416. InFIG. 11D, force on the compressible/deformable member 420 has increaseddue to subject motion. As a result, the light-shuttering pathways 422are compressed decreasing the amount of light that can pass therethroughto the optical detector. The modulation of the amount of light reachingthe optical detector 416 can be correlated to subject motion and amotion reference signal can be generated via a processor.

Referring now to FIGS. 12A-12C, a biometric sensor module 500 thatincludes an internal mechanical apparatus (e.g., a pressure transducer)520 configured to capture motion information from the body of a subjectwearing the sensor module 500 is illustrated. The illustrated sensormodule 500 includes a base 510, such as a printed circuit board (PCB),supporting a plurality of optical emitters 512 and an optical detector516. The sensor module 500 also includes a plurality of members 530extending therefrom that are configured to engage the skin of a subjectwearing the sensor module 500. Forces imparted upon the members 530 as aresult of subject motion are transferred to the pressure io transducer520 and measured. The modulation of pressure in the pressure sensor canbe correlated to subject motion and a motion reference signal can begenerated via a processor.

Referring now to FIG. 13A, according to other embodiments of the presentinvention, pressure variation information may be obtained by wrapping alimb 600 of a subject with a fluid filled expansion bladder 610, thenconstraining the bladder 600 to prevent expansion away from the limb 600with a band 620 having low or no compliance (i.e., low or nostretchiness). The illustrated band 620 supports a biometric sensormodule 630, such as a PPG sensor module. The non-stretchy (i.e.,inelastic) band 620 can be incorporated as part of the expansion bladder610 itself by constructing the bladder 610 from a semi-compliantmaterial. One example of this could be a polyurethane coated nylonmaterial that is RF welded together to form a pouch. This type of aconstruction will allow some stretch, but will retain a limited shapewithin the functional pressure range and effectively function as asemi-constrained system. Through this configuration, pressure changeswithin the limb of a subject wearing the bladder 610 can be directlytransferred to the fluid filled pouch.

The fluid within the bladder 610 can be any suitably stable liquid, gas,or gel (water, a water solution, air, silicone, colloid(s), and thelike), and pressure transducers (not illustrated) can be employed withinthe bladder volume to transmit a signal proportional to the change ininternal pressure. Exemplary pressure transducers include MEMS(micro-electromechanical systems) devices, diaphragms, actuators, etc.In addition, an optical scatter sensor (such an optomechanical pressuresensor) may be used to sense optical scatter upon motion of the bladder610 in proportion to changes in pressure.

In order for the bladder 610 to interact with the limb 600 of thesubject to pick up pressure readings, it may be necessary for thebladder 610 to interact with the limb 600 by maintaining good surfaceinteraction with the limb 600. Tightening the band 620 around thebladder 610 of fixed volume can force the bladder 610 to interact withthe limb 600 and experience deformation and pressure changes frompressure changes within the limb 600. Without such constraint, thebladder 610 may dislocate outside of the band 620 and parts of thebladder 610 may then not couple well with the limb 600. However, if arigid or semi-rigid band does not fully surround the bladder 610, asemi-constrained bladder system may also provide good coupling betweenthe limb 600 and the pressure sensitive bladder 610. In such case, itmay be necessary to pump or fill gas (manually or automatically) withinthe bladder 610 to prevent dislocation of the bladder 610 outside of theband 620.

The use of a compliant bladder, such as bladder 610 illustrated in FIG.13A, can be advantageous because a large surface area can interact withthe limb 600 over a large proportion of the surface area of the limb600. In the illustrated embodiment of FIG. 13A, the bladder encirclesthe limb 600 and pressure changes relate to compression of the entirecross-sectional area of the limb 600. In this way, a processorassociated with the PPG sensor 630 receives information about thepressure changes throughout the entire limb cross-sectional area as thelimb 600 can be fully contained within the pressure interrogation area.However, a partial bladder (non circumferential) may also be used suchthat only part of the limb 600 can interact with the bladder 610. Insuch case, the bladder 610 may be preferably located near the site ofthe biometric sensor location, such that the motion noise referencelocation (the pressure sensing location) and biometric sensing locationare in proximity. Additionally, although FIG. 13A is drawn towards alimb (such as an arm, wrist, leg, etc.), embodiments of the presentinvention may be applied towards digits (fingers and toes) as well asother parts of the body that can support an encircling or partiallyencircling device.

Referring now to FIGS. 13B-13D, a modular bladder 640 according toembodiments of the present invention is illustrated. A PPG sensor module630 is positioned on top of a substrate 650 (such as a circuit board orother support structure having electrical connections for powering thesensor module 630), and the substrate 650 may rest on top of the bladder640. Thus, when integrated into a wearable device (i.e., such as awearable band 620, FIG. 13D), the bladder 640 experiences a compressiveforce (i.e., pressure) when the PPG sensor module 630 makes contact withthe skin, pushing on the substrate 650 and hence the bladder 640 incontact therewith. A pressure sensor 660 in the bladder 640 detects thispressure so that it can be used as a noise reference, as described belowwith respect to FIG. 17.

The pressure sensor 660 may be any of a variety of different types ofpressure sensors that can be embedded in a wearable sensor module, asdescribed below. In addition, although one pressure sensor 660 is shown,a plurality of pressure sensors may be utilized.

FIGS. 13A-13E illustrate several concepts: 1) reducing pressure andpressure changes on a sensor module, and 2) using the pressuremeasurement of the bladder fluid as a noise reference of bloodocclusion. The changes of pressure of a sensor head, device case,straps, and the like of a wearable device on the skin of a subject tendsto modulate the blood's proximity to the surface of the skin byocclusion. More pressure tends to occlude blood away from the surface,while less pressure allows the blood to move back towards the surface.It can be advantageous to reduce and redistribute the total pressure onthe face of a sensor head against the skin of a subject. The sensor headcan be mounted with a fluid filled bladder to act as a pressure absorberto reduce the pressure between sensor head and the skin. The fluid canbe air (or other suitably inert gas), silicone, gel, liquid water (orother suitably inert liquid), or the like. By shaping the bladder 640 ofFIGS. 13B-13E as a ring surrounding the sensor head/module 630, thepressure can be redistributed equally across the sensor head/skincontact so as to reduce spots of blood occlusion, especially at thecorners or near the optical path of the sensor head.

The bladder 640 also acts to reduce the rate of change of pressure ofthe sensor head/module 630 against the skin, as happens during vigorousactivities or during muscle movements in the area of the sensorhead/module 630. The bladder 640 acts to reduce the suddenness of changeof pressure of the system. This is advantageous for the sensor signalquality to avoid sudden changes in measurements. A choice of bladderfluid may be made to most effectively balance the pressure reducingeffect overall, to most effectively redistribute pressure, or to mosteffectively reduce pressure changes.

Because PPG sensors are sensitive to changes in blood flow,pressure-related blood flow may be a source of noise on the measuredoptical signal of the sensor head/module 630 during motion or muscleflexing during a user's activities. For example, flexing muscles maypush away blood in such a way that the resulting PPG signal shows thecharacteristics of a heartbeat pulse wave during muscle flexing,confusing algorithms designed to extract heart rate from the PPG signal.

To allow an algorithm to account for this noise, it can be advantageousto know the pressure of the sensor head/module 630 against the skin sothat it may be used as a noise reference. The amount of pressure insidethe bladder 640 of FIGS. 13B-13E may be directly related to the amountof pressure between the sensor head/module 630 and the skin. By couplinga pressure sensor 660 to the fluid within the bladder, the measurementcan be estimated as a measurement of the pressure of the blood occlusionforce. A choice of bladder fluid may be made to closely represent thefluid dynamics of the skin/blood system such that it most closelycorrelates with the contributing noise, such that noise subtractionresults in a cleaner PPG signal more closely related toheartbeat-induced blood flow. For example, in the optomechanicalconfiguration of a pressure sensor, where an optical emitter shineslight into the fluid and an optical detector detects light scatteredfrom the fluid, wherein the scattered light intensity is proportional tothe fluid motion, the desired optical detector signal would closelycorrelate with the unwanted venous blood motion component (non-pulsatilecomponent) of the blood flow signal captured by the associated PPGsensor.

An exemplary configuration of such a representation is presented in FIG.13F, which illustrates a bladder 670 wherein the fluid-filled regioncomprises artificial blood vessels 680 at least partially filled withfluid 682. In such a configuration, the bladder may be comprised ofcompliant (compressible) material, such as plastic, polymer material,silicone, rubber, latex, or the like, such that a compression of thematerial will result in a skin-like (i.e., human skin-like) compression,pushing the fluid 682 from the artificial fluid reservoirs 690 acrossthe artificial vessels 680. Though the artificial vessels 680 are shownas mostly lateral structures, they may be orientated as mostly verticalstructures or other predominate directions, as with real human bloodvessels. In one non-limiting embodiment of FIG. 13F, the bladder 670 maybe constructed by molding silicone (or other suitable material) aroundan artificial blood vessel mold. In another non-limiting embodiment, theartificial blood vessels 680 may be fabricated by molding silicone (orother suitable material) without the artificial blood vessel molds inplace. Rather, the blood vessel structures may be fabricated bygenerating intentional bubbles in the silicone. The fluid may be filledwithin the vessels 680 by soaking the bladder 670 in fluid or exposingthe bladder 670 to fluid and sealing up the structure (such as byovermolding or the io like) to create a non-leaking unit.

In another embodiment of FIG. 13F, the artificial structure (i.e., thebladder 670) may further comprise microfluidic or nanofluidic circuitsand structures to control the fluid flow within the artificialstructure. A variety of micro- and nano-fluidic circuits and structuresare well-known in the art. It should be noted that the particularembodiment of FIG. 13F can be especially useful as a noise reference forboth heart rate monitoring and blood pressure monitoring, as thepressure signal generated may be more indicative of venous blood flowthan the other embodiments of FIGS. 13A-13E. Moreover, a further benefitof using the configuration of FIG. 13F as a noise reference is thatphysical contact of the artificial structure 670 with the skin may notbe required, as fluid will flow during motion and be sensed by thepressure (or optical) sensor even without a pressure differentialbetween a wearable device utilizing the artificial structure 670 and thebody of the subject.

Referring now to FIGS. 14A-14B, a sensor module 700 having an array ofoptomechanical motion noise reference sensors 710 (having, for example,one or more of the optomechanical configurations described in thevarious embodiments of the present invention) for tracking gesturalmotion is illustrated. The sensor module 700 is attached to the limb ofthe subject via a band 720. The optomechanical motion sensors 710 areapplied in an array along the body (in this case a limb) to sensepressure or to sense motion changes between the array elements and thebody of the subject. Thus, as the subject generates gestures, the arrayelements 710 may sense the pressure generated by these gestures, andthese signals may be processed to recognize the gestures. Because thelocation of the optomechanical sensors with respect to each other isknown in advance by their layout in the wearable device, a processor cananalyze the sensor readings to map out the muscle-movement-inducedpressure readings across the body, converting sensor information intogestural information.

The wearable array may also be in communication with a localaccelerometer, and combined accelerometry data plus array data may beprocessed to determine gross body part motion as well as gesturalmotion. This functionality may be achieved because the accelerometer maybe configured to assess gross acceleration, angular momentum, magneticlocation, etc., whereas the array may be configured to sense pressuresignals from gestures. It should be noted that in a strictly gesturalmonitoring system, a biometric sensor is not necessarily needed, but anintegrated biometric sensor may also be added to the embodiment in orderto provide biometric sensing in addition to gestural sensing.

Head or ear motions or gestures also may be assessed via embodiments ofthe present invention. One or more optomechanical sensors or sensorarrays 710 may be integrated into an audio earpiece and configured tomeasure scattered light signals from body motion caused by footsteps,speaking, yawning, chewing, and the like. The output of theoptomechanical sensor may then be processed to extract footsteps andmouth motions. Signals associated with mouth motions may be processed todetermine what words a subject is speaking or what words someone is“mouthing” (not technically speaking, but generating the mouth motionsfor a word). These signals may then be used to control a user interfaceor to be translated into true sounds. For example, by mouthing the wordfor “turn on”, the optomechanical sensor output may be processed(locally or remotely) into a command to turn on a smartphone, theearpiece itself, or some other device.

Reference is now made to FIGS. 15A-15E. FIG. 15E is a spectrogram of araw PPG signal collected from a person wearing a PPG sensor in proximityof the person's skin. FIGS. 15A-15B show normalized spectrograms for aPPG-derived heart rate signal, following active motion-noisecancellation employing embodiments of the present invention andembodiments of co-owned U.S. Patent Application Publication Nos.2014/0114147, 2015/0018636, and 2015/0011898, which are incorporatedherein by reference in their entireties.

A person wearing an armband having a PPG sensor module, according toembodiments of the present invention, was exercising via a strengthtraining technique that involved the following exercises: rowing,inchworms, and thrusters. The PPG armband comprised both an inertialsensor (a 3-axis accelerometer) and an optomechanical sensor (aninternal optomechanical sensor). During the PPG signal collection,frequencies associated with motion noise, and harmonics thereof, wereactively removed in real-time via spectral subtraction and redaction asdescribed in U.S. Patent Application Publication Nos. 2014/0114147,2015/0018636, and 2015/0011898.

FIGS. 15A-15B show the PPG spectrograms for this exercise sessionfollowing active noise removal. However, FIG. 15A shows the spectrogramof the PPG signal where only the accelerometer was used as a noisereference, and FIG. 15B shows the spectrogram of the PPG signal whereboth the accelerometer and an optomechanical sensor according toembodiments of the present invention were used as a noise reference.Note that for FIG. 15B, the heart rate information is clearly visible inthe spectrogram for all exercises. However, in FIG. 15A, the heart rateinformation for the first part of the exercise, in this case rowing, wasnot adequately extracted. The origin for this noteworthy differencebetween FIG. 15A and FIG. 15B may be elucidated by viewing thenormalized spectrograms of FIG. 15C, which is the z-axis of theaccelerometer and FIG. 15D, which is the optomechanical sensor output.Namely, the spectrogram of optomechanical sensor output of FIG. 15Dreflects the noise in the raw PPG spectrogram of FIG. 15E much moreclosely (as is evinced by the low frequency noise in FIG. 15E).

In contrast, the spectrogram of the accelerometer output does not asclosely reflect the noise characteristics of the raw PPG spectrogram.Thus, subtraction of unwanted frequencies is more effective whenincluding the optomechanical information of FIG. 15D, yielding a moreaccurate representation of user heart rate (FIG. 15B as opposed to FIG.15A. For noise removal, it is important to note that one may choose touse either the accelerometer signal or the optomechanical signal todetermine a user cadence and then use this cadence information todetermine harmonics for redaction (i.e., redacting harmonics of runningcadence from the PPG signal). But each noise reference may be used forspectral subtraction, either individually or combined.

It should be noted that a myriad of noise removal techniques may beapplied with the optomechanical pressure signal as a noise reference.For example, the optomechanical signal may serve as the input to anadaptive filter such that the noise reference is actively removed fromthe raw PPG signal in real time. FIGS. 16A-16C are spectrogramsillustrating real time noise removal from a PPG signal. Thesespectrograms are intensity-normalized in each time slice, and come fromthe same subject executing a CROSSFIT®-style exercise test over thecourse of 600 seconds, while the subject was wearing a PPG sensor havingan internal optomechanical sensor, as shown in FIGS. 9A-9D. FIG. 16Apresents io a spectrogram of a PPG signal (the biometric information)following a DC-removal filter. A heart rate signal is barely visible inthis spectrogram, and motion noise is apparent. FIG. 16B presents aspectrogram of the associated optomechanical signal (the motion noisereference) following a DC-removal filter. The motion noise is clearlypresent in the spectrogram. FIG. 16C presents a spectrogram of theoutput of an adaptive filter (i.e., an LMS or “least-mean-squares”adaptive filter) used to subtract the optomechanical information fromthe PPG signal information in accordance with embodiments of the presentinvention (removing the features of FIG. 16B from that of FIG. 16A).Note that the heart rate signal “pops out” from the spectrogram once themotion noise is removed. In particular, the common noise between theoptical signal and the optomechanical signal (the noise less than 50BPM) is removed in FIG. 16C. Also, much of the motion noise between 50and 80 BPM is removed between 230 and 350 seconds in FIG. 16C.

Exemplary adaptive filters are describe in co-owned U.S. Pat. Nos.8,700,111 and 8,647,270, which are incorporated herein by reference intheir entireties. Moreover, as illustrated in FIG. 17, an optomechanicalsensor according to embodiments of the present invention may be usedfirst as a noise reference in a subtracting time-domain adaptive filter,effectively removing or subtracting motion noise from a PPG signal togenerate a cleaner PPG signal, and then this cleaned-up PPG output maybe the input of a parameter extractor using the accelerometer as a noisereference and/or using the accelerometer to determine user cadence andimplement heuristics for estimating heart rate, as described in theaforementioned U.S. patents. Optionally, the accelerometer may also beused as a 2nd noise reference in the adaptive filter to further clean upthe PPG signal before the output reaches the parameter extraction stage.

In the illustrated embodiment of FIG. 17, signals 900 and 902 from asensor module according to embodiments of the present invention areinput to a subtractive filter 904. Signal 900 is a signal containingprimarily physiological information from a subject (i.e., physiologicalinformation obtained via a biometric information optical pathway 40),and signal 902 containing primarily subject motion information (i.e.,motion information obtained via a biometric information optical pathway30). The subtractive filter 904 removes motion noise from the biometricsignal using the motion information pathway signal as a noise reference,and the cleaned-up biometric signal is input to the parameter extractor906 which is configured to produce digital data strings includingvarious physiological data.

Combined with the motion pathway information signal 902, theaccelerometer 908 associated with the sensor module may be used as anadditional noise reference and/or to determine user cadence andimplement heuristics for estimating heart rate. For example, as shown inFIG. 17, motion information from both the accelerometer 908 and motioninformation pathway signal 902 may be subtracted from the biometricinformation pathway signal 900. Similarly, both the accelerometer 908and motion information pathway signal 902 may provide motion informationto a processor as a basis for redacting harmonics associated with bodymotion from the biometric pathway signal.

Additionally, the accelerometer 908 signal and the motion informationpathway signal 902 may be processed by a processor such that one ofthese signals filters or modifies the other signal. This can be usefulfor the case where it is beneficial for the two signals to have similarcharacteristics (i.e., similar amplitudes, pulse widths, phases, peakfrequencies, harmonics, etc.) in the time- or frequency-domain prior tothe noise removal step (904, 1002) in actively cleaning up the biometricpathway signal 900. In such case, a step between 1000 and 1002 in FIG.18 may be configured to “normalize” the intensity of the either theaccelerometer 908 or motion pathway signal 902 based on the output ofthe other.

It should be noted that FIG. 17 should not be considered a limitingmethod of signal extraction for a clean PPG signal using the motioninformation pathway signal 902 as a noise reference, but rather anexemplary method. As described earlier, a variety of filteringmethodologies may be applied to clean up the biometric informationpathway signal 900 using the motion information pathway signal 902 as anoise reference. Moreover, in the embodiment shown in FIG. 17, thesubtractive filter 904 may comprise a simple subtraction filter, anadaptive filter, a heuristic filter, or the like. As described earlier,the filter may also comprise a redaction approach to selectively removesignals (such as unwanted frequencies) from the biometric informationpathway signal 900 using the motion information pathway signal 902and/or accelerometer 908 signal as a noise reference. A redactionapproach can be especially useful for removing unwanted spectralharmonics of motion noise from the biometric information pathway signal900.

As described earlier, in some embodiments of FIG. 17, the subtractivefilter 904 may further comprise a spectral transform generator such thatthe subtraction process proceeds in the frequency domain. It should benoted that, in general, the filters used to remove motion noise asdescribed herein may be analog and/or digital in nature, and thesubtractive filter 904 may comprise at least one digital algorithmand/or may comprise an analog filter. A static or active analog filtermay be used, but an active analog filter may be more beneficial as itmay facilitate the active removal of time-dependent motion noisecharacteristics.

It should also be noted that although heart rate extraction is discussedat length regarding embodiments of the present invention, the inventionis not limited to heart rate monitoring. A cleaned-up PPG sensor outputmay also be processed to extract other parameters, such as RRi,breathing rate, blood pressure, SpO₂, blood hydration level, vascularcompliance, heart rate variability (HRV), blood analyte levels,mathematical operations on the waveform (such as integrals, derivatives,transforms, and the like), and various other blood-flow-relatedproperties (such as blood flow rate, volume, density, and the like), andthese parameters may be processed together (i.e., by a processor in awearable device) and organized in a data output such as a serial orparallel data stream.

Referring to FIG. 18, an exemplary method of utilizing variousembodiments of the optomechanical sensors described herein, perhapsusing the system of FIG. 17, is illustrated. Optical scatter data isalternately collected from the biometric information pathway signal 900and motion information pathway signal 902 by alternating pulsing of theoptical emitters associated with the respective pathways (Block 1000).For example, the emitter(s) associated with one pathway may be in apower-on state when emitter(s) from the other pathway is in a power-offstate.

A subtractive filter, such as subtractive filter 904, is applied to thecollected data using the motion information pathway signal 902 as amotion noise reference to generate a cleaner biometric signal (Block1002). Biometric parameter information is then extracted from thebiometric signal (Block 1004) and communicated to another device orsystem (Block 1006). It may be beneficial to communicate the extractedbiometric parameter information as a serial string of consecutive valuesrepresenting the biometric values of each extracted biometric parameter.Moreover, it may be beneficial for the serial string to compriseinformation about the type of biometric parameter and the confidence inthe value of the biometric parameter [see U.S. patent application No.8,923,941, which is incorporated herein by reference, in its entirety.

Embodiments of the present invention are not limited to “wearable”embodiments (i.e., embodiments where a sensor module or monitoringdevice is worn by a subject). Embodiments of the present invention alsomay be applied in “one-touch” or acute sensing applications. Forexample, FIG. 19 illustrates a biometric sensor module 2000 for a fingeror other digit F. The illustrated sensor module 2000 is an internaloptomechanical sensing module having first and second optical emitters14, 16, and an optical detector 18, as described above. The illustratedsensor module 10 also includes a stabilizer member 22 that is configuredto transfer motion information from the finger F of the subject to theoptical detector 18 such that when the digit F is pressed upon thebiometric sensor module, this motion information (such as that caused byskin displacement, pressure changes, blood displacement, and the like),is transferred to the stabilizer member 22, modulating the lightscattered in the motion noise pathway. The illustrated sensor module2000 produces two optical pathways 30, 40. The first optical pathway 30(the “motion information pathway”) is created by light emitted by thefirst optical emitter 14 and reflected off of the stabilizer member 22.The second pathway 40 (the “biometric information pathway”) is createdby light emitted by the second optical emitter 16 that is absorbed,scattered, and/or reflected by tissue, blood vessels, etc., within thefinger F of the subject. The biometric information pathway 40 contains ahigher level of subject physiological information than the motioninformation pathway 30, which may contain a higher level of subjectmotion information than physiological information.

The sensor module 2000 of FIG. 20 is similar to the sensor module 2000of FIG. 19 except that an optical barrier 20 is provided to preventlight emitted by the emitter 14 from being exposed to the user's skin.(Note that in FIG. 19 there may be a small gap where light from theemitter 14 may reach the skin of the user. The barrier 20 in FIG. 20 canprevent this.) This barrier 20 may be critical when using the motionnoise pathway signal as a noise reference during biometric parameterextraction (FIGS. 17 and 18), as it is important that the motion noisesignal has little or no physiological information that mightinadvertently be removed from the biometric pathway signal during thebiometric parameter extraction process.

As with other embodiments described herein, the optical detector 18 canbe shared or each pathway (i.e., the biometric information pathway andmotion information pathway) may have its own detector. Sharing the samedetector has the benefit of potentially improving the linearity (insignal amplitude and phase, for example) between unwanted motion noisein the biometric information pathway signal 40 and motion noise detectedby the motion information pathway signal 30.

The light guiding region 52 of the biometric information pathway and thelight modulating region 50 of the motion information pathway may eachinclude pliable materials, such as optically transparent silicone. Thelight modulating region 50 is covered with an optically opaque or lightscattering stabilizer 22 (such as a light-scattering layer, an opaquesilicone, or other opaque and pliable material). In this way, bothbiometric (PPG) and motion information may be captured by the opticaldetector 18. However, it should be noted that the function of the motioninformation pathway is to capture motion information, and this may beachieved with rigid material, as well, e.g., via vibrations in a rigidsolid. For example, the light guiding/modulating regions may utilizepolycarbonate, glass, or other rigid, optically transparent materials.Alternatively, the light guiding region 52 of the biometric informationpathway may be comprised of rigid material and the light modulatingregion 50 of the motion information pathway may be comprised of pliablematerial.

The stabilizer(s) may preferably be comprised of pliable material, butit is possible to use rigid material that is sufficiently opaque oranother material that can scatter light with body motion. Importantaspects of the stabilizer are: a) it must not be optically transparent,as light from the emitter 14 should not reach the skin of the user, andb) it must be able to scatter light proportional to body motion suchthat moving the digit F against the stabilizer should modulate lightscattered in the motion noise pathway.

Although FIGS. 19 and 20 illustrate an internal optomechanical sensorconfiguration, it should be noted that an acute sensing embodiment mayalso be achieved using external optomechanical embodiments, such asthose illustrated in FIGS. 3-5, 7 as well as the other internaloptomechanical embodiments described herein.

FIGS. 21 and 22 illustrate an optomechanical sensor configuration as itmay be applied to an electronic device 2100, such as a smartphone orother electronic device. The illustrated device 2100 includes afinger-shaped indentation 2102 that is configured to receive a portionof a subject's finger therein. An optomechanical sensor module 2120,such as illustrated in FIGS. 19 and 20, is located within thefinger-shaped indentation 2102. The optomechanical sensor module 2120may be any of the internal or external optomechanical sensor modulesdescribed herein.

A plurality of stabilizing elements 2104 are positioned within thefinger-shaped indentation 2102 and are configured to support andstabilize a subject's finger F at the location of the optomechanicalsensor 2120. These stabilizing elements may be like members 222 in FIG.9. Namely, they are not meant to transfer motion information (unlikestabilizing members 232 and 234 in FIG. 9), but rather are used forstabilizing (supporting) the sensor at the body.

This illustrated configuration may be particularly useful for one-touchacute sensing of PPG-related biometrics, such as heart rate, respirationrate, blood pressure, hydration level, metabolic rate, cardiac output,blood analyte levels, blood oxygen levels, hemodynamics, and the like.In some embodiments, to enhance blood perfusion during PPG measurements,thereby increasing the signal-to-noise of the PPG waveform information,a vibrational motor within the smartphone 2100 may be engaged toencourage blood flow to the outer layers of the skin of the finger F,perhaps controlled via an algorithm as described below with respect toFIG. 23.

The various optomechanical sensor modules described herein may becombined with a blood flow stimulator to help increase blood perfusionin the area of the body interrogated by optical radiation. A blood flowstimulator may be integrated within a sensor module or an electronicdevice comprising a sensor module (such as the smartphone 2100illustrated in FIGS. 21 and 22). A variety of blood flow stimulationmethodologies may be implemented, including, but not limited to:thermal, electrical, mechanical, acoustical, and electromagnetic. Forexample, a heating element for blood flow stimulation may comprise aresistive heating filament, an infrared (IR) heater (alsoelectromagnetic), or the like may be integrated into a sensor module oran electronic device comprising the sensor module. An electrical elementfor blood flow stimulation may comprise one or more electrode pairs. Amechanical blood flow stimulator may comprise a motor or othermechanical actuator, such as piezoelectric actuator, acoustomechanicalactuator, thermomechanical actuator, electroactive actuator, and thelike.

In addition, the actuator used within a smartphone to generate hapticfeedback may be used to stimulate blood flow, for example, by initiatinga vibrational sequence during a PPG measurement process. An acousticalelement may comprise an acoustical generator for generating sonic (orultrasonic) waves that encourage blood flow below the opticalinterrogation zone of the optomechanical sensor module.

Because many smartphone and other electronic devices include vibrationalactuators, no new mechanical hardware may be necessary for blood flowstimulation. An algorithm, such as that shown in FIG. 23, and describedbelow, may be applied to stimulate blood flow, interrogate the skin withlight, remove motion noise, and generate a PPG-derived biometric.

In contrast, integrating other types of blood flow stimulators intosmartphones and other electronic device may require additionalconsiderations. For example, it may be important for a resistive heatingelement to be in thermally conductive communication with askin-interface thermal conductor for coupling thermal energy between theresistive heater and a subject's skin. Similarly, a skin-interfaceelectrical conductor may be important for coupling electrical energybetween the embedded electrodes and the skin. Moreover, a thin layer ofgold or conductive polymer may be important for preventing corrosion ordegradation of such skin-interface conductors. For the case of aradiative IR heater, an IR-transparent optical window (such as sapphire,IR-transparent ceramics, metal fluorides, metal selenides, silicon,germanium, and the like) may be important for coupling thermal energybetween the IR heater and the subject's skin.

Referring now to FIG. 23, a method that may be implemented inconjunction with an optomechanical sensor module and blood flowstimulator to improve PPG measurements, according to some embodiments ofthe present invention, is illustrated. The method may be executed by oneor more processors in communication with the sensor outputs from anoptomechanical sensor module. For example, in some embodiments, themethod of FIG. 23 may be controlled by a processor running a smartphoneapp.

The illustrated method may start by first determining if a subject'sskin is in sufficient proximity to a optomechanical sensor using aproximity detection routine (Block 1100), such as via an opticalthreshold detection methodology, sensor fusion, or similar proximitydetection methods. If the skin is deemed to be sufficiently close to thesensor, then the processor(s) may determine whether the blood flow(perfusion) beneath the user's skin is sufficient (Block 1104), forexample, using a signal quality detection methodology. Because theoptomechanical sensor is a PPG sensor, this can be achieved by analyzingthe quality of the PPG waveform, the signal-to-noise ratio of the PPGsignal, blood oxygen level using SpO2 sensing, or the like. Examples ofsuch PPG signal quality methodologies are described in U.S. ProvisionalPatent Application Ser. No. 62/056,510, the contents of which isincorporated herein by reference in its entirety. Once proximity isconfirmed and perfusion is deemed by the algorithm to be sufficient,biometric calculations may then be executed to generate at least onePPG-based biometric (Block 1108). If the perfusion is deemed to beinsufficient (Block 1104), then a blood flow stimulator may be engagedto stimulate blood flow and to continue operation until the perfusion isdeemed to be sufficient for at least one biometric measurement (Block1106). Although this example of implementing the method of FIG. 23 isgiven with respect to integration within a smartphone, the method may beexecuted via virtually any sufficiently powerful processor andassociated circuitry of other electronic devices.

FIGS. 24 and 25 illustrate the combination of an optomechanical sensormodule and blood flow stimulator, according to some embodiments of thepresent invention. FIG. 24 is a top view of a device 2200, such as asmartphone or other electronic device, in which an optomechanical sensormodule 2202 is integrated. The device includes skin interface elements2204, 2206 which may be electrodes, thermal conductors, acousticgenerators, electromagnetic (i.e., IR) radiators, mechanical actuators,or the like, depending on the methodology used to stimulate perfusion(blood flow).

FIG. 25 is a cross-sectional view of the device 2200 of FIG. 24 andillustrates a thermally conductive blood flow stimulator (BFS) 2204 andan IR (radiative) BFS 2206. For the thermally conductive BFS, anair-filled void or other heat conduction medium may be used to conductheat from the resistive heater to the skin interface thermal conductor.For the case of the IR BFS, a vacuum, an air-filled void, or otherIR-transparent medium may be used, since the stimulation energy isradiative and not conductive.

It should be noted that although two blood flow stimulators (2204, 2206)are shown in FIG. 25, it may not be necessary to have both in a device.Rather, these two stimulators are shown to represent how each might beintegrated into a device. In some cases, the optomechanical sensormodule 2200 may be surrounded by an array of blood flow stimulators ofthe same type (i.e., all thermal, all IR, all acoustic, all electrical,etc.) or of a plurality of types.

FIG. 29 is a top view of a device 2200, such as a smartphone or otherelectronic device, in which an optomechanical sensor module 2202 isintegrated. The illustrated device 2200 includes a BFS 2204 in the formof a resistive heater having a heating element 2205 is at the surface ofthe skin interface. A variety of resistive heaters suitable for heatinghuman skin are well known in the art. Also shown in FIG. 29 is apiezoelectric actuator membrane 2210, which may alternatively, oradditionally, be used to stimulate blood flow at the area of the bodyilluminated by the optomechanical sensor module 2202.

Embodiments of the present invention may include micro- ornano-fabricated devices. For example, FIGS. 26A-26D illustrate anintegrated micro-fabricated optomechanical sensor module 3000 fabricatedusing standard micro-manufacturing processes commonly used to fabricateMEMS devices. FIG. 26A is a side view of the optomechanical sensormodule 3000, and FIG. 26D is a top plan view of the optomechanicalsensor module 3000. FIGS. 26A-26C illustrate a potential fabricationsequence for generating the module 3000 of FIGS. 26C-26D.

The illustrated optomechanical sensor module 3000 includes four mesaLEDs 3002, two of which are utilized for the biometric signal pathway,and two utilized for the motion (noise) pathway. In the illustratedembodiment, the LEDs 3002 may be comprised of AlxlnyGa1—x—yN,AlxlnyGa1—x—yAs, or other optoelectronic materials, and the substrate3004 may be sapphire, SiC, AlxlnyGa1—x—yN, AlxlnyGa1—x—yAs, silicon, orother suitable material. In the illustrated embodiment, the LEDelectrodes are not shown for simplicity, but in principle a suitablelayout would be for the electrodes to extend to the periphery of thesubstrate surface, protected under oxide, and exposed for wirebonding atthe periphery. Similarly, opaque barrier regions between the LEDs 3002,which may be useful for preventing direct light contamination fromneighboring LEDs 3002, are not shown for simplicity.

The LEDs 3002 may be forward biased to emit light and reverse-biased todetect light. Thus, if at least one LED 3002 in each pathway isforward-biased and at least one other LED 3002 is reverse-biased, then asuitable optical emitter-detector combo may be achieved. Thus, areverse-biased LED may behave as an optical detector as describedherein.

Numerous methods of generating a micro-fabricated optomechanical module3000, according to embodiments of the present invention may be utilized.For example, once the LEDs 3002 are fabricated, one method is toselectively deposit a sacrificial layer 3006 and a support layer 3008over the motion pathway LEDs 3002. Then, as shown in FIG. 22B, thesupport layer 3008 may be etched down a few microns followed by aselective deposition of a membrane layer 3010. An important function ofthe membrane layer 3010 (analogous to the stabilizer 22 described inFIGS. 19-20) is to move with motion and to scatter light generated bythe forward-biased LED 3002 so that the reverse-biased LED 3002 maycollect the motion noise information. As shown in FIG. 22C, thesacrificial layer 3006 can then be removed to provide a membrane 3010over the motion pathway LEDs 3002, supported by the etched-back supportlayer 3008. A variety of sacrificial layers, support layers, andmembrane layers are well known to those skilled in the art and come froma non-limiting list of oxides, nitrides, metals, polymers, andsemimetals.

FIG. 27 illustrates a system 4000 for generating high-quality PPG dataand communicating this data to a secondary device or system, accordingto some embodiments of the present invention. The illustrated system4000 can be integrated within a single discrete electronic module or canbe distributed throughout, or embedded within, another electronic device(such as the smartphone 2100 shown in FIGS. 21 and 22). The dotted-linearound the biometric pathway 4006 and motion noise pathway 4008 is meantto emphasize that these pathways are most likely to be integrated withina discrete module 4004 as described above (e.g., sensor module 2000 ofFIGS. 19-20, etc.). One specific embodiment of such a system isillustrated in FIGS. 21-22. For example, the power circuitry 4002, A/Dcircuitry 4010, blood flow stimulator and associated circuitry 4014, andcommunication circuitry 4012 may all be part of the existing hardwareinside a smartphone, such as smartphone 2100 of FIGS. 21-22. Theoptomechanical sensor module 4004 is powered by the smartphone circuitryand communicates information with the smartphone circuitry.

However, in another specific embodiment, all of the functional blocks ofFIG. 27 may be integrated together in a discrete module, such as aprinted electronics circuit board (PCB) with supporting housing,optomechanics, or the like. In some embodiments, a secondary device orsystem may comprise a remote system or device, and communication betweenthe two systems may occur via standard electrical or wireless protocols.

FIG. 28 depicts how embodiments of the present invention may beintegrated into an earpiece 5000. Though only one optomechanical sensormodule may be required for generating clean PPG information, multipleoptomechanical sensor modules 5002 are shown at various locations of theearpiece 5000, representing potentially good locations for coupling bothphysiological and motion information between the ear and the module. Theoptomechanical sensor modules may be either internal or externaloptomechanical embodiments, or combinations of both, as describedearlier. The illustrated earpiece 5000 includes a housing 5004surrounded, at least partially, by a cover 5006, and a speaker driver5008 within the housing 5004.

The combinational stimulation-sensor system of FIGS. 24, 25, and 29,comprising a sensor module 2202 and blood flow stimulator(s) 2204, 2206,2208, may further comprise at least one biometric temperature sensor2220, exposed to the skin, to collect thermal data from the illuminatedregion of the body for estimating the temperature of the skin, blood, orother tissue in proximity to the blood flow stimulator. The biometrictemperature sensor 2220 is configured to be proximal to a blood flowstimulator (e.g., 2204, 2206, 2208) and in thermal communication withthe skin of the user. Such a sensor 2220 may comprise a biometrictemperature sensing element coupled to a skin interface thermalconductor. As a specific example, such a sensor may comprise a iotemperature-sensing IC (integrated circuit) coupled to an exposedmetallic contact (the skin interface thermal conductor), such that theexposed metal contact, when in contact with the skin of the user,transfers thermal energy to the sensing element for generating anelectrical signal comprising skin temperature information. Numerouswearable skin temperature sensing configurations are well known to thoseskilled in the art, and various types of thermal sensing elements—an IC,thermistor, thermocouple, IR sensor, RTD (resistance temperaturedetector), or the like—may be employed along with various thermalconductors.

In the illustrated system 4000 of FIG. 27, the blood flow stimulator4014 comprises a thermal generator and biometric temperature sensor 4016worn proximal to the skin, as described above. The system 4000 may beemployed towards temperature-dependent sensing of blood and tissue(i.e., skin, muscle, etc.) which is interrogated by both light fromoptical emitter(s) of the sensor module 4000 (e.g., sensor module 2202of FIGS. 24, 25, 29) and thermal energy from skin interface element(s)of one or more blood flow stimulators 4014. In combination with aprocessor, the system 4000 can be used to actively control stimulationas well as to actively characterize biometric information from the bloodor tissue.

The thermal information collected by the biometric temperature sensor4016 may be processed by a processor to: 1) estimate the temperature ofthe skin, blood, or tissue that is being illuminated by the opticalemitter of a PPG sensor module, and 2) gauge the thermal dosage appliedto the skin by the blood flow stimulator 4014, providing feedback foractive control of the thermal energy dosage. For example, an algorithmexecuted by the processor may process the thermal energy information todetermine if the dosage is higher or lower than a determined threshold.In such case, the processor may then communicate information to thecontrolling electronics that the intensity of the blood flow stimulationis to be reduced or increased accordingly. Such a configuration may helpprevent burning of the skin while assuring that enough thermal energy issupplied to generate sufficient blood perfusion in the illuminated bodyregion.

Additionally, a stimulation-sensor system+biometric temperature sensor,according to embodiments of the present invention, may also be appliedtowards temperature-dependent biometric characterization. For example,with supporting analog and/or digital control electronics/circuitry,light generated by an optomechanical sensor module (e.g., sensor module2202 of FIGS. 24, 25, 29) may be time-synchronized with a thermal bloodflow stimulator to execute temperature-dependent biometric analysis ofthe blood, skin, or tissue via temperature-dependent optical absorption,scattering, polarization, and/or luminescence. Namely, since theinteraction between light and biological materials may change withchanges in temperature, analyzing the PPG signal from the system 4000during multiple skin, blood, or tissue temperatures can be used toidentify the presence and concentration of skin, blood, and tissueconstituents.

As a specific example, the intensity vs. optical wavelengthcharacteristics of biological luminescence of a body region, typicallyinduced by illuminating the body region with optical wavelengths between200 nm and 490 nm, is known to depend on the temperature of the bodyregion, and this temperature dependence may be different for differingluminescent species. Thus, by controlling the localized body temperatureover set ranges and recording luminescence intensity over those settemperature ranges—or even more so by recording optical excitationwavelength-dependent luminescence intensity over those temperatureranges—and then analyzing these wavelength-dependent luminescenceintensities in context of biological luminescence models, constituentsof the localized excitation region may be characterized.

Referring to FIG. 30, in one embodiment, the system 4000 of FIG. 27, forexample, may be applied towards generating physiological assessmentsby: 1) first determining if the blood perfusion level is acceptable formeasurement (Block 6000), such as via the method described above withrespect to FIG. 23, 2) taking measurements of both biometric opticalsensor data and biometric temperature sensor data (Block 6002), 3)analyzing the optical sensor data in context of the temperature sensorinformation (Block 6004), and 4) generating a physiological assessmentbased on the analysis of this data (Block 6006). This method isparticularly well-suited for collecting PPG optical scatter data withchanges in the temperature of an illuminated region. Key functionalbenefits of this methodology include: 1) power savings may be achievedby executing PPG analysis only when the subject's perfusion status isacceptable, and 2) reducing PPG analysis errors (such as PPG-based bloodpressure measurement errors, for example) by collecting PPG data onlywhen the subject's perfusion status is acceptable.

In another embodiment, the temperature control of the body region ofinterest (the skin and associated blood vessels, blood, etc.) may bemore deliberate once viable perfusion status is determined, as shown inFIG. 31. In the method illustrated in FIG. 31, the blood flowstimulator—in this case a thermal energy generator—is turned on and offfor certain periods of time; during these periods of time, sensorreadings are collected and stored (in memory) from both the biometricoptical and temperature sensors (Blocks 6010, 6012). If the PPG sensormodule (comprising the optical emitter(s) and detector(s)) is configuredto generate light at multiple wavelengths, optical sensor data at eachwavelength may be stored for each on/off cycle of thermal energygeneration. This may be achieved by cycling through each individualwavelength in time at a set duty cycle or by utilizing an opticaldetector configured to selectively detect light over a plurality ofindividual wavelength ranges, as described in U.S. Pat. Nos. 8,251,903and 8,700,111, the contents of which are incorporated herein byreference in their entireties. The PPG and temperature sensor data isanalyzed for “on” and “off” periods of the blood flow stimulator (e.g.,a thermal energy generator) to generate a physiological assessment(Block 6014).

As an example of a type of physiological assessment, hemodynamicassessments may be generated by processing the PPG data from both “on”and “off” cycles of the blood flow stimulator (thermal energygenerator). As a specific example, the intensity of PPG peaks (i.e., theamplitude of the PPG waveform of one or more blood flow pulses) may becompared for both “on” and “off” cycles, and the ratio of the amplitudeof PPG intensity during “on” cycles vs. “off” cycles can be used toassess how sensitive a subject's blood flow dynamics may with respect toambient temperature or various forms of body temperature.

According to another embodiment of the present invention illustrated inFIG. 32, thermal energy generator intensity of a blood flow stimulatormay be adjusted to various settings such that a matrix of optical sensorsignal intensities over a range of temperatures (and over a range ofoptical wavelengths if multiwavelength emitters are employed) may begenerated. This matrix may then be used to generate physiologicalassessments based on a io biological model.

For example, according to the method illustrated in FIG. 32, a bloodflow stimulator (e.g., a thermal energy generator) is turned on andthermal intensity is adjusted to a controlled setting (Block 6020). Skintemperature is determined by sensing thermal information from the skinusing the temperature sensor, and collecting PPG data from the skin witha peak optical emitter intensity centered at λ₁ (Block 6022). The stepsof Blocks 6020 and 6022 are repeated over a controlled range of thermalintensity settings to create a dataset containing PPG relatedinformation versus temperature (Block 6024). The steps of Blocks 6020,6022 and 6024 are then repeated for each desired wavelength (λ_(n)) overa range from n=1 to n=k (Block 6026). The temperature vs. PPG amplitudevs. λ matrix is then analyzed to generate a physiological assessment forthe subject (Block 6028).

An example of how the method of FIG. 32 may be applied is presented inFIG. 33, showing a plot of optical scatter (PPG) signal intensity &bioluminescence signal intensity vs. measured skin temperature formultiple optical excitation wavelengths (λ₁, λ₂, λ₃, λ_(n)). Twoexemplary temperatures, Temp₁ and Temp_(n), are presented on the plot,showing how a matrix of optical intensity—optical(Temp_(n)λ_(n))—may begenerated, such that this matrix may be applied towards generating aphysiological assessment based on a biological model. Although thecollected optical energy detected by an optical sensor may compriseoptical scatter or optical luminescence information from multiple blood,skin, or tissue constituents, having optical sensor data from multipleoptical wavelengths at multiple temperatures helps provide enough datato characterize “n” constituents with “n” unknowns, as withmulti-wavelength pulse oximetry.

For the case where luminescent blood, skin, or tissue constituents areof interest, the method illustrated in FIG. 34 may be employed togenerate a matrix of temperature-dependent optical intensities overtime—optical(Temp_(n)λ_(n)t_(n))—over an optical scattering time periodt_(scatt) and an optical luminescence period t_(lum). For example, asillustrated in FIG. 34, a blood flow stimulator (e.g., a thermal energygenerator) is turned on and an optical emitter of a PPG sensor module isturned on (Block 6030). A determination is made if skin temperature hasreached a first threshold value and remains stable at that value and, ifso, then PPG data is collected from skin at this first threshold valuestarting at t=0 of a time period t_(on) (Block 6032). This measurementcan be repeated for multiple excitation wavelengths. At time t=t_(s),the blood flow stimulator (e.g., a thermal energy generator) is turnedoff and time-correlated skin temperature data and PPG data is collectedover the time period t_(off) (Block 6034). This measurement may berepeated for multiple excitation wavelengths. The PPG and temperaturesensor data is analyzed over the time periods t_(on) and t_(off) togenerate at least one physiological assessment for the subject (Block6036).

It should be noted that although the λ value in FIG. 34 represents thepeak optical excitation wavelength—λ_(excit)—the optical luminescencecollected may be at multiple luminescence wavelengths—λ_(lum)—for agiven λ_(excit) if a multiwavelength optical detector is utilized in thePPG sensor module, as described above. An advantage of the method ofFIG. 34 is that data may be collected for both PPG optical scatter andbioluminescence, and the characteristic temperature dependence of bothoptical properties may be collected and analyzed to generatephysiological assessments.

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. The invention is defined by the following claims, withequivalents of the claims to be included therein.

That which is claimed is:
 1. A sensor module configured to be worn by a subject, the sensor module comprising: a housing; at least one optical emitter and at least one optical detector supported by the housing; and a stabilizer member movably supported by the housing, wherein the stabilizer member comprises a portion that extends through a first aperture in the housing and that is configured to engage a body of the subject; wherein the at least one optical emitter is configured to direct light through a second aperture in the housing and into the body of the subject via a first optical pathway and to direct light at a portion of the stabilizer member within the housing along a second optical pathway, and wherein the at least one optical detector is configured to detect light from the body of the subject via a third aperture in the housing and generate a first signal comprising subject physiological information, and wherein the at least one optical detector is configured to detect light scattered by the stabilizer member and generate a second signal comprising subject motion information.
 2. The sensor module of claim 1, wherein the at least one optical emitter comprises at least one first optical emitter configured to direct light into the body of the subject via the first optical pathway, and at least one second optical emitter configured to direct light at the stabilizer member along the second optical pathway.
 3. The sensor module of claim 1, wherein the first and second optical pathways are optically isolated from each other, and/or wherein the housing comprises substantially opaque material.
 4. The sensor module of claim 1, further comprising a light guide supported by the housing and wherein the at least one optical emitter is configured to direct light into the body of the subject via the light guide.
 5. The sensor module of claim 4, wherein the light guide comprises a plurality of portions that extend through respective apertures in the housing and are configured to engage portions of the body of the subject.
 6. The sensor module of claim 1, further comprising at least one signal processor configured to process the first and second signals so as to remove motion artifacts from the first signal.
 7. The sensor module of claim 1, wherein the sensor module is configured to be positioned at or within an ear of the subject, secured to an appendage of the subject, integrated within a wearable device, and/or integrated within clothing worn by the subject.
 8. The sensor module of claim 1, further comprising a blood flow stimulator configured to increase blood perfusion at a location of the body of the subject receiving light via the first optical pathway.
 9. A method of removing motion artifacts from a biometric signal generated by a sensor module worn by a subject, wherein the sensor module includes a stabilizer member, at least one optical emitter, and at least one optical detector, the method comprising: directing light from the at least one optical emitter into a body of the subject via a first optical pathway; directing light from the at least one optical emitter at the stabilizer member along a second optical pathway; detecting light from the body of the subject and generating a first signal comprising subject physiological information; detecting light scattered by the stabilizer member and generating a second signal comprising subject motion information; and processing the first and second signals so as to remove motion artifacts from the first signal.
 10. The method of claim 9, wherein the at least one optical emitter comprises first and second optical emitters, and wherein the method comprises directing light from the first optical emitter into the body of the subject via the first optical pathway, and directing light from the second optical emitter at the stabilizer member along the second optical pathway.
 11. The method of claim 9, wherein the at least one optical detector comprises first and second optical detectors, and wherein the method comprises detecting light from the body of the subject and generating a first signal comprising subject physiological information via the first optical detector, and detecting physically modulated light scattered by the stabilizer member and generate a second signal comprising subject motion information via the second optical detector.
 12. The method of claim 9, wherein the first and second optical pathways are optically isolated from each other. 